STRATEGIC
ALLIANCE AGREEMENT
THIS
STRATEGIC ALLIANCE AGREEMENT is made as of December 9,
2005
(the “Effective
Date”),
by
and between DISCOVERY LABORATORIES, INC., a Delaware corporation (“Discovery”),
and PHILIP
MORRIS USA INC., d/b/a CHRYSALIS TECHNOLOGIES, a Virginia corporation
(“Chrysalis”).
Discovery and Chrysalis shall be referred to herein individually as a
“Party”
and
collectively as the “Parties”.
WHEREAS,
Discovery is currently developing a portfolio of aerosolized surfactant
replacement therapies (aSRT)
based upon its proprietary precision-engineered surfactant technology for
the
prevention and treatment of respiratory disorders;
WHEREAS,
Chrysalis is currently developing and has expertise in the development
and
design of proprietary technology for the aerosolization of pharmaceutical
products; and
WHEREAS,
the Parties desire to enter into a strategic alliance pursuant to which
they
will develop certain combination drug-device surfactant products, Chrysalis
will
license its proprietary aerosolization technology to Discovery, and Chrysalis
will provide certain additional consultative services to Discovery in connection
with combination drug-device surfactant products, all on the terms and
conditions set forth herein.
NOW,
THEREFORE, in consideration of the foregoing premises and the representations,
warranties, covenants, and agreements contained herein, the Parties, intending
to be legally bound, hereby agree as follows:
ARTICLE
1
DEFINITIONS
In
addition to terms defined elsewhere in this Agreement, the following terms
used
in this Agreement are defined below:
1.1 “AAA”
means
the American Arbitration Association.
1.2 “Actual
Amount”
has the
meaning set forth in Section 8.7.2.
1.3 [***]
1.4 “Additional
Product Opportunities”
has the
meaning set forth in Section 4.9.1.
Information
marked by [***]
has been omitted pursuant to a request for confidential treatment. The
omitted
portion has been separately filed with the Securities and Exchange
Commission.
1.5 “Aerosol
Device”
means a
device for the aerosolization of a pharmaceutical compound for administration
to
humans. It is contemplated that the Aerosol Device shall consist of (i)
permanent (e.g.,
nondisposable) components that control power and electronics (e.g.,
control unit) and (ii) a physical mechanism (e.g.,
pump)
to provide a means for dispensing the Drug Product from the container closure
system.
1.6 “Aerosol
Technology”
means
any technology related to the aerosolization of a liquid form of a
pharmaceutical compound. Aerosol Technology does not include technology
that is
related to the delivery of aerosols as dry powders.
1.7 “Affiliates”
means
with respect to any Party, any Person, directly or indirectly, controlling,
controlled by or under common control with such Party. For purposes of
this
Section 1.7, “control” means (i) in the case of a Person that is a
corporate entity, direct or indirect ownership of more than fifty percent
(50%)
of the stock or shares having the right to vote (or such lesser percentage
which
is the maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) for the election of directors of such Person or (ii) in the
case
of a Person that is an entity, but is not a corporate entity, the possession,
directly or indirectly, of (A) more than fifty percent (50%) of the economic
or
partnership interest in the income or capital of such Person or (B) the
power to
direct, or cause the direction of, the management or policies of such Person,
whether through the ownership of voting securities, by contract or otherwise;
and the terms “controlling,” “controlled by” or “under common control”
shall have the meanings correlative to the foregoing.
1.8 “Agreement”
means
this Strategic Alliance Agreement, including the Schedules attached
hereto.
1.9 “Alliance”
has the
meaning set forth in Article 2.
1.10 “Alliance
Manager”
has the
meaning set forth in Section 5.2.1.
1.11 “Base
Hospital General Product”
has the
meaning set forth in Section 4.2.
1.12 “Base
NICU Product”
has the
meaning set forth in Section 4.2.
1.13 “Base
Supported Product Development Projects”
means a
Supported Product Development Project with respect to a Base NICU Product
or a
Base Hospital General Product.
1.14 “Breaching
Party”
has the
meaning set forth in Section 17.1.1 and 17.1.2, as applicable.
1.15 “Business
Day”
means a
day other than a Saturday, Sunday, or other day on which commercial banks
in New
York, New York are authorized or required by Law to close.
1.16 “Chrysalis”
has the
meaning set forth in the Preamble hereto.
1.17 “Chrysalis
Intellectual Property”
has the
meaning set forth in Section 9.1.1.
1.18 “Chrysalis
Patents”
means
all Patents owned by Chrysalis or to which Chrysalis otherwise has rights
that
claim or are directed to the Chrysalis Technology.
1.19 “Chrysalis
Technology”
means
(a) Chrysalis’ proprietary Aerosol Technology (including without limitation the
technologies, devices, processes, equipment, materials and know-how relating
to
the aerosolization of liquid forms of drug products and the Aerosol Devices
and
Disposable Dose Packs therefor) and (b) all Intellectual Property owned
by or
licensed to Chrysalis relating to such Aerosol Technology, including, without
limitation, the Chrysalis Patents.
1.20 “Chrysalis
Technology Improvements”
means
any Inventions created or reduced to practice [***]
in the
performance of the Alliance or exercise of the license granted pursuant
to this
Agreement, which Inventions relate primarily to the Chrysalis
Technology.
1.21 “Clinical
Trials”
means
Phase I, II, III and, if required, Phase IV clinical trials and such other
tests
and studies in human subjects or patients that are required to obtain,
maintain,
or sustain Regulatory Approval in a country in the Territory.
1.22 “Combined
Net Sales”
means
with respect to any Contract Year, the total Net Sales of all of the Supported
Products during such Contract Year.
1.23 “Committees”
has the
meaning set forth in Section 5.1.
1.24 “Confidential
Information”
means
all information received by either Party or its Affiliates from or on behalf
of
the other Party or its Affiliates relating to this
Alliance that the disclosing Party treats as confidential, including, without
limitation: (i) copies of any nonpublic information regarding a Party’s Patents;
(ii) techniques, technology, practices, trade secrets, inventions (whether
or
not patentable), designs, methods, manufacturing processes, formulae,
formulations, specifications, documents, knowledge, know-how, skill, experience,
test data, and results, (including that related to pharmacology, toxicology,
preclinical testing, clinical testing, expression data, Chemistry, Manufacturing
and Control (CMC) data, batch records, trials, and studies, safety and
efficacy,
analytical, and quality control); (iii) devices and related components,
compounds, polypeptides, proteins, formulations, compositions of matter,
cells,
cell lines, markers, assays, and physical, biological, or chemical material;
(iv) marketing information, market research data, medical/physicians advisory
boards, and consultant input, including clinical studies designed to support
promotional efforts;
(v) the
terms of this Agreement, and (vi) other proprietary business information
such as
business plans, financial or personnel matters, present or future products,
research, process and technology development programs, sales, suppliers,
customers, employees, investors, or other business information, whether
in oral,
written, graphic, or electronic form.
1.25 “Contract
Month”
means
each month during any Contract Year. The initial Contract Month will be
deemed
to begin on the Effective Date and end on the expiration of that Contract
Month
in which the Effective Date falls.
Information
marked by [***]
has been omitted pursuant to a request for confidential treatment. The
omitted
portion has been separately filed with the Securities and Exchange
Commission.
1.26 “Contract
Quarter”
means
each three (3) month period ending on March 31, June 30, September
30 and
December 31 during any Contract Year. The initial Contract Quarter will
be
deemed to begin on the Effective Date and end on the expiration of that
Contract
Quarter in which the Effective Date falls.
1.27 “Contract
Year”
means a
twelve (12) month period ending on December 31. The initial Contract Year
will
be deemed to begin on the Effective Date and end on December 31 of that
Contract
Year in which it falls.
1.28 “Design
Review Board”
has the
meaning set forth in Section
5.7.
1.29 “Diligent
Commercialization Efforts”
means
efforts and resources reasonably comparable to those commonly used in the
research-based pharmaceutical industry for a medical device, pharmaceutical
product or pharmaceutical compound at a similar stage in its commercialization
or product life of similar market potential, taking into account safety
and
efficacy, the competitiveness of alternative products in the marketplace,
the
patent and other proprietary position of the product, the likelihood of
regulatory approval given the regulatory structure involved, the potential
profitability of the product and alternative products and other relevant
factors
relating to the commercialization of a Licensed Product, including, without
limitation, the potential cost, risk, timing and reward, provided,
however,
that
the fact that the Parties are required to share revenues with respect to
the
Licensed Products shall not be a factor taken into account in determining
whether Diligent Commercialization Efforts were satisfied. Diligent
Commercialization Efforts shall be determined on a market by market basis
for a
particular Licensed Product, and it is anticipated that the level of effort
will
change over time reflecting changes in the status of the Licensed Product
and
the market involved.
1.30 “Diligent
Development Efforts”
means
efforts and resources reasonably comparable to those commonly used in the
research-based pharmaceutical industry for a medical device, pharmaceutical
product or pharmaceutical compound at a similar stage in its development
of
similar market potential, taking into account safety and efficacy, product
profile, difficulty in developing the product, competitiveness of alternative
products in the marketplace, the patent and other proprietary position
of the
product, the likelihood of regulatory approval given the regulatory structure
involved, the potential profitability of the product and alternative products
and other relevant factors affecting the cost, risk and timing of development
and total potential reward to be obtained if a Licensed Product is
commercialized, provided,
however,
that
the fact that the Parties are required to share revenues with respect to
the
Licensed Products shall not be a factor taken into account in determining
whether Diligent Development Efforts were satisfied.
1.31 “Discovery”
has the
meaning set forth in the Preamble hereto.
1.32 “Discovery
Intellectual Property”
has the
meaning set forth in Section 9.1.2.
1.33 “Discovery
Patents”
means
all Patents owned by Discovery or to which Discovery otherwise has rights
that
claim or are directed to any Discovery Intellectual Property.
1.34 “Discovery
Technology”
means
(a) Discovery’s proprietary Pulmonary Surfactant technology (including without
limitation the technologies, formulations, processes, equipment, materials
and
know-how relating to the manufacture and use of Pulmonary Surfactants for
treatment of respiratory conditions), and (b) all Intellectual Property
owned by
or licensed to Discovery relating to such Pulmonary Surfactant technology,
including, without limitation, the Discovery Patents.
1.35 “Discovery
Technology Improvements”
means
any Inventions created or reduced to practice [***]
in the
performance of the Alliance or exercise of the license granted pursuant
to this
Agreement, which Inventions relate primarily to Pulmonary Surfactants (alone
or
in combination with other pharmaceutical compounds).
1.36 “Disposable
Dose Packet”
consists of: (i) Drug Product within a container (comprising the drug
formulation containing the drug substance and the container closure system
in
which it is packaged), (ii) aerosolization capillary (heatable capillary
through
which the formulation is pumped to produce an aerosol), (iii) patient interface
(components through which the aerosol produced by the capillary travels
in order
to reach the patient), and (iv) all ancillary tubing, connectors and fittings
related thereto.
1.37 “Dispute”
has the
meaning set forth in Section 20.1.
1.38 “Dollars”
and
“$”
means,
unless otherwise specified, United States Dollars.
1.39 “Drug
Product”
means
Pulmonary Surfactant(s) or other pharmacological agent(s), together with
any
excipients or inactive ingredients, formulated for use in a Licensed
Product.
1.40 “Effective
Date”
has the
meaning set forth in the Preamble hereto.
1.41 “Estimated
Amount”
has the
meaning set forth in Section 8.7.1.
1.42 [***]
1.43 “Exchange
Act”
has the
meaning set forth in Section
19.1.
1.44 “Exclusive
Field”
means
the therapeutic or preventative use in humans of Aerosol Technology to
deliver
Pulmonary Surfactants (alone or in combination with any other pharmaceutical
compound(s)) as an active ingredient for the prevention or treatment of
Respiratory Indications.
1.45 “FDA”
shall
mean the United States Food and Drug Administration, and any successor
agency.
1.46 “First
Access Product”
has the
meaning set forth in Section 10.1.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
1.47 “First
Access Product Presentation”
has the
meaning set forth in Section 10.3.
1.48 “First
Commercial Sale”
means
the first arms-length commercial sale of a Licensed Product to a Third
Party by
Discovery or its Affiliates or sublicensees, as the case may be, in any
country
in the Territory after receipt of Marketing Authorization in such country
which
results in an exchange for cash or some equivalent to which value can be
assigned for the purpose of determining Net Sales.
1.49 “Force
Majeure Event”
means
an event or occurrence that materially interferes with the ability of a
Party to
perform its obligations or duties hereunder which is not within the reasonable
control of the Party affected or any of its Affiliates, not due to malfeasance
by such Party or its Affiliates, and which could not with the exercise
of due
diligence have been avoided, including without limitation fire, earthquake,
acts
of God, acts of war, labor strikes or lockouts, riots, civil disturbances,
actions or inactions of governmental authorities (except actions in response
to
a breach of applicable Law by such Party).
1.50 “GAAP”means
generally accepted accounting principles in the United States of America.
1.51 “Hospital
General Products”
has the
meaning set forth in Section 4.2.
1.52 “Hospital
Setting”
means a
hospital-setting in the delivery room, NICU, PICU, CCU, emergency department,
surgical care unit and/or intermediate care unit.
1.53 “Indemnitee”
has the
meaning set forth in Section 15.2.1.
1.54 “Indemnitor”
has the
meaning set forth in Section 15.2.1.
1.55 “Independent
Product”
means
any Licensed Product other than a Supported Product.
1.56 “Infringement
Notice”
has the
meaning set forth in Section 9.6.1.
1.57 “Intellectual
Property”
means
all know how, Inventions, Patents, copyrights, trademarks, trade secrets
and any
other intellectual property rights in the Territory that may be secured
in any
place under laws now or hereafter in effect.
1.58 “Invention”
means
any new or improved apparatus, process, information, product, invention,
discovery, idea, suggestion, material, data, equipment, design, circuit
component, drawing, tooling, prototype, report, computer software, documentation
or other intellectual property or know-how (whether or not patentable)
discovered, produced, conceived, created or reduced to practice by either
or
both Parties (or their Affiliates, sublicensees, subcontractors, successors
or
assigns).
1.59 “Joint
Inventions”
has the
meaning set forth in Section 9.1.3.
1.60 “Joint
Patents”
means
all Patents that claim or are directed to any Joint Inventions.
1.61 “Law”
means
any applicable statute, law, ordinance, regulation, order, or rule of any
federal, state, local, foreign, or other governmental agency or body or
of any
other type of regulatory body (including common law) or securities exchange
or
automated quotation system.
1.62 “Licensed
Product”means
a
combination drug-device product using or otherwise practicing the Chrysalis
Technology and delivering Pulmonary Surfactants (alone or in combination
with
other pharmaceutical compounds).
1.63 “Losses”
has the
meaning set forth in Section
15.1.1.
1.64 “Major
Markets”
means
[***].
1.65 “Marketing
Authorization”
means,
with respect to each country in the Territory, the principal
Regulatory Approval required to market the Product in such country (e.g.,
the
NDA), including satisfactory pricing and reimbursement approval, when
applicable.
1.66 “NDA”
shall
mean (a) a new drug application, biologics license application, pre-market
approval application, or a pre-market clearance under FDCA Section 510k
that may
be filed with the FDA in the United States or any comparable application
that
may be filed with any equivalent Regulatory Authority in the
Territory.
1.67 “Net
Sales”
means,
with respect to Licensed Products, as applicable, sold by Discovery, its
Affiliates and sublicensees, the [***]
amount
[***]
for
Licensed Products by Discovery, its Affiliates, and any sublicensees of
Discovery in arms-length, commercial transactions with customers that are
Third
Parties, less the following deductions to the extent included in such
[***]
amount:
[***]
Any
discretionary rebates, discounts or other adjustments to the [***]
amount
shall be commercially reasonable and consistent with standard industry
practices. Net Sales (including each applicable deduction from the [***]
amount)
shall be determined from the books and records of Discovery maintained
in
accordance with GAAP consistently applied.
1.68 “NICU”
means
neonatal intensive care unit.
1.69 “NICU
Products”
has the
meaning set forth in Section 4.2.
1.70 “Non-Breaching
Party”
has the
meaning set forth in Section 17.1.1 and 17.1.2, as applicable.
1.71 “Party”
and
“Parties”
have
the meanings set forth in the Preamble hereto.
1.72 “Party
Vote”
has the
meaning set forth in Section 5.6.3.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately
filed with the Securities and Exchange Commission.
1.73 “Patents”
means
all patents and patent applications, and all patents issuing thereon (including
utility, model and design patents and certificates of invention), together
with
all reissue patents, patents of addition, divisions, renewals, continuations,
continuations-in-part, substitutions, additions, extensions (including
supplemental protection certificates), registrations, confirmations,
re-examinations, and foreign counterparts of any of the foregoing in the
Territory.
1.74 “Person”
means
any natural person, corporation, company, partnership, limited liability
company, proprietorship, trust or estate, joint venture, association, or
other
legal entity.
1.75 “Phase
2 Completion Point”
has the
meaning set forth in Section 10.2.
1.76 “Project
Plan”means
a
plan for the overall development and commercialization of Licensed Products
pursuant to a Supported Product Development Project.
1.77 “Project
Team”
has the
meaning set forth in Section 5.4.1.
1.78 “Pulmonary
Surfactant”
means
surface active agents designed for deposition in the lungs in order to
exert a
physiological or pharmacological affect to prevent or treat Respiratory
Indications.
1.79 “Regulatory
Approval”
means
any approvals (including, where necessary for the marketing, use, or other
distribution of a drug, medical device, or combination drug and medical
device
in a regulatory jurisdiction, pricing, and reimbursement approvals), licenses,
registrations, or authorizations or equivalents necessary for the manufacture,
use, storage, import, export, clinical testing, transport, marketing, sale,
and
distribution of the Drug Product or Aerosol Device and any Licensed Product
in a
regulatory jurisdiction anywhere in the Territory, including Marketing
Authorizations.
1.80 “Regulatory
Authority”
means
any federal, national, multinational, state, provincial, or local regulatory
agency, department, bureau, or other governmental entity with authority
to
regulate the marketing and sale of a pharmaceutical product, delivery system
or
device in a country in the Territory, including the FDA in the United
States.
1.81 “Regulatory
Data”
means
any and all research data, pharmacology data, chemistry, manufacturing,
and
control data, preclinical data, clinical data and/or all other documentation
submitted, or required to be submitted, to Regulatory Authorities in association
with an Investigational New Drug Application or NDA for Licensed Products
(including any Drug Master Files, Device Master Files, Chemistry, Manufacturing
and Control (CMC) data, or similar documentation). “Respiratory
Indications”
means
all respiratory dysfunctions, failures, syndromes, diseases, disorders,
or
conditions.
1.82 “Right
of First Access”
has the
meaning set forth in Section 10.1.
1.83 “Royalty
Credit”
has the
meaning set forth in Section 8.7(b).
1.84 “Royalty
Report”
means
the reports to be delivered by Discovery to Chrysalis pursuant to Section
8.6
with respect to each Contract Month and pursuant to Section 8.7 with respect
to
each Contract Quarter, which reports shall give such particulars of each
of the
Licensed Products sold by Discovery and its Affiliates and sublicensees
during
the preceding Contract Month in the case of Section 8.6 and during the
preceding
Contract Quarter in the case of Section 8.7 on a country-by-country basis
as are
reasonably pertinent to perform an accounting of royalties under this Agreement.
1.85 “SEC”
has the
meaning set forth in Section 11.3.
1.86 “Steering
Committee”
has the
meaning set forth in Section 5.3.1.
1.87 “Supported
Product”
means:
(i) the NICU Product, (ii) the Hospital General Product, and (iii) any
other
Licensed Products deemed to be Supported Products pursuant to Section 4.9.
1.88 “Supported
Product Development Projects”
has the
meaning set forth in Section 4.1.
1.89 “Target
Indications”
means
the following Respiratory Indications: Respiratory Distress Syndrome (RDS);
Chronic Lung Disease (BPD); Transient Tachypnea; Hypoxemia; Pulmonary
Hypertension; Pneumonia; Bronchiolitis; Diaphragmatic Hernia; Acute Lung
Injury
(ALI); Acute Respiratory Distress Syndrome (ARDS); Lung Transplantation;
Respiratory Syncitial Virus (RSV); and, Cystic Fibrosis.
1.90 “Target
Populations”
means
human patients in a Hospital Setting receiving forms of treatment for the
applicable Respiratory Indication that are typically and principally provided
within a Hospital Setting. For the sake of clarity, Target Populations
shall not
include patients or forms of treatment which are typically rendered outside
a
Hospital Setting or in ambulatory or chronic care modalities, even if such
forms
of treatment are also administered in a Hospital Setting.
1.91 “Taxes”
has the
meaning set forth in Section 8.13.
1.92 “Term”
has the
meaning set forth in Article
16.
1.93 “Territory”
means
all countries in all continents of the world.
1.94 “Third
Party”
means
any Person other than Chrysalis or Discovery or their respective
Affiliates.
1.95 “Third
Party Claim”
has the
meaning set forth in Section 15.1.1.
1.96 “Valid
Claim”
means a
claim of an issued and unexpired patent, which claim has not been held
unpatentable, invalid, or unenforceable by a court or other government
agency of
competent jurisdiction from which no appeal can be or has been taken and
has not
been held or admitted to be invalid or unenforceable through re-examination
or
disclaimer, opposition procedure, nullity suit or otherwise, which claim,
but
for the licenses granted herein, would be infringed by the sale of a Licensed
Product.
1.97 “Working
Group”
has the
meaning set forth in Section 5.5.
ARTICLE
2
SCOPE
OF ALLIANCE
The
Parties agree to enter into this Agreement for the general purpose of developing
and licensing for manufacturing and commercialization by Discovery certain
combination drug-device products to promote and enhance human health on
the
terms and conditions set forth herein (the “Alliance”).
To
facilitate the development of such products, pursuant to this Agreement,
Chrysalis is granting Discovery a license under the Chrysalis Technology,
Chrysalis and Discovery have agreed to work together to develop certain
combination drug-device products and Chrysalis has agreed to provide certain
additional consultative services to Discovery, all on the terms and conditions
set forth herein. Except as set forth in this Agreement or otherwise agreed
to
in writing, the Parties shall have no rights and obligations with respect
to the
Alliance. The Parties agree at all times to act in good faith and in a
cooperative manner and, subject to any contractual or legal restrictions,
to
share such information as reasonably necessary to facilitate each Party’s
performance of its obligations hereunder under this Agreement.
ARTICLE
3
LICENSE
3.1 License.
Subject
to the terms, conditions, and limitations of this Agreement, Chrysalis
hereby
grants to Discovery an exclusive right and royalty-bearing license or
sublicense, as applicable, with the right to grant sublicenses solely as
set
forth in Section 3.3 under the Chrysalis Technology and Joint Patents
to
make and have made, to use and have used, to sell and have sold, to offer
for
sale and have offered for sale, to import and export and have imported
and
exported Licensed Products in the Exclusive Field in the Territory during
the
Term.
3.2 Limitations.
The
license granted pursuant to Section 3.1 shall be exclusive only to the
extent
that Chrysalis has the right to grant an exclusive license with respect
to the
Licensed Product in question. No right or license outside of the Exclusive
Field
is granted and all such rights are expressly reserved by Chrysalis. No
right or
license is or shall be granted under this Agreement by implication. All
such
rights or licenses are or shall be granted only as expressly provided in
this
Agreement. Discovery shall not practice the Chrysalis Technology except
as
expressly licensed herein. Nothing herein shall limit the ability of Chrysalis
to perform any research or development work on or using the Chrysalis
Technology. Notwithstanding any other provision of this Agreement, no rights
with respect to any trademarks, trade names, service marks or logos of
Chrysalis
are granted pursuant to this Agreement.
3.3 Sublicensing
Rights.
The
license granted to Discovery pursuant to Section 3.1 by Chrysalis shall
include
the right of Discovery to grant sublicenses, subject to terms and conditions
set
forth in Section 21.6. Discovery shall provide Chrysalis with prompt written
notice of any sublicenses granted hereunder.
3.4 Retained
Rights.
Any
rights of each Party not expressly granted to the other Party under the
provisions of this Agreement shall be retained by each Party, and, subject
to
any applicable terms, conditions, and limitations of this Agreement, each
Party
shall retain the right to: (a) exploit such Party’s own Intellectual Property
relating to Licensed Products to develop, manufacture, and commercialize
products outside the Exclusive Field; (b) exploit such Party’s own Intellectual
Property relating to Licensed Products for other purposes outside the Exclusive
Field unrelated to the Licensed Products; and (c) perform its obligations
and
exercise its rights under this Agreement.
3.5 Exclusivity.
In
light of the substantial investments and undertakings to be made by each
Party
in connection with the Alliance in order to successfully develop and bring
to
market products to enhance human health, each Party agrees that the Alliance
shall be exclusive in the Exclusive Field. Accordingly, during the Term,
neither
Party shall without the other Party’s prior written consent directly or
indirectly offer for sale or sell, or grant any third party the right to
offer
for sale or sell any Aerosol Device, Disposable Dose Packet or Drug Product
for
use in the Exclusive Field other than a Licensed Product.
ARTICLE
4
PRODUCT
DEVELOPMENT
4.1 In
General.
In
light of Chrysalis’ substantial expertise regarding the Chrysalis Technology and
Discovery’s substantial expertise regarding Pulmonary Surfactants, Discovery
desires to have Chrysalis work with Discovery on the development of certain
of
the Licensed Products. The Parties have agreed to work together on Supported
Product projects (the “Supported
Product Development Projects”)
with
the objective of developing Licensed Products on the terms and conditions
set
forth in this Article 4.
4.2 Supported
Product Development Projects.
As of
the Effective Date, the Parties have agreed to work together on the following
Supported Product Development Projects to develop aerosolized Pulmonary
Surfactant products for use in the Hospital Setting: (i) a project to develop
an
initial aerosolized Pulmonary Surfactant product for the prevention and
treatment of Respiratory Indications in neonates in the NICU (the initial
Licensed Product resulting therefrom, the “Base
NICU Product”
and,
together with any other NICU-related Licensed Products, the “NICU
Products”);
and
(ii) a project to develop an initial aerosolized Pulmonary Surfactant product
for the prevention and treatment of Respiratory Indications in patients
outside
of the NICU (the initial Licensed Product resulting therefrom, the “Base
Hospital General Product”
and,
together with any other non-NICU-related Licensed Products, the “Hospital
General Products”).
As soon
as practicable after the Effective Date, the Project Team shall mutually
agree
upon and submit to the Steering Committee for approval a Project Plan for
each
of the Base Supported Product Development Projects. Licensed
Products that may be developed other than the Base NICU Product and the
Base
Hospital General Product shall be treated as Additional Product Opportunities
as
provided for in Section 4.9.
4.3 Project
Plans.
The
Project Plans for each Supported Product Development Project shall, subject
to
the Steering Committee’s right to modify or add to the following requirements in
its discretion, include: (i) a list of development activities (including
preclinical studies, toxicology work, Clinical Trials, Clinical Trial material
requirements, specifications and other key activities required for obtaining
Marketing Authorizations and timelines for the performance of the development
activities; (ii) a reasonably detailed and specific budget for such development
activities; and (iii) Discovery’s plan for commercialization (including timing
and plans for Discovery obtaining Marketing Authorizations in the Major
Markets). The Parties acknowledge that the Project Plan budgets are intended
to
provide an estimation of expenditures and resource deployment and are not
required to disclose sensitive data on either Party’s cost structure (for the
sake of clarity, Parties are expected to provide reasonable detail on such
items
as aggregate costs for relevant cost categories (e.g., personnel and overhead
expenses) but are not expected to provide data regarding individual personnel
costs or line-by-line overhead cost classifications). The Project Team
shall be
responsible for the preparation of the budget for each Project Plan. The
Project
Plans for each Supported Product Development Project shall be updated,
amended
and modified as deemed necessary by the Project Team, but no less frequently
than each Contract Year. Updated Project Plans shall be submitted by the
Project
Team to the Steering Committee for approval in a timely fashion by a date
that
is determined from time-to-time by the Steering Committee that shall conform
to
the greatest practicable extent the Parties’ respective internal budgeting
cycles. Neither Party will pursue development tasks or product studies
relating
to Supported Product Development Projects not provided for in the Project
Plans
prior to presenting such proposals to the Steering Committee and obtaining
authorization therefor from the Steering Committee.
4.4 Development
Responsibilities and Consulting Services.
4.4.1 Direction
and Oversight.
All
development activities in connection with Supported Product Development
Projects
shall be conducted under the direction and oversight of the Steering Committee
and the Project Team. In order to facilitate effective management of the
projects each Party shall have lead responsibility for particular aspects
of the
development as set forth below in Sections 4.4.2 and 4.4.3(b), as appropriate.
Each Party shall also reasonably support the other Party as provided for
in the
relevant Project Plan to facilitate such other Party’s ability to perform its
development responsibilities. Chrysalis shall also provide consulting to
Discovery with respect to certain of Discovery’s responsibilities as set forth
below in Section 4.4.3(c).
4.4.2 Responsibilities
of Discovery.
The
specific activities to be undertaken by Discovery in connection with each
project and the Supported Products developed pursuant thereto shall be
as set
forth in the applicable Project Plan. Discovery shall act as the lead Party
for,
and shall be principally responsible for performing, the
following activities with respect to each project: (i) drug product formulation
development; (ii) development and implementation of analytical methods
for
quality assurance/control of Drug Product, Aerosol Device and Disposable
Dose
Packet; (iii) manufacturing of Supported Products, including manufacturing
of
the Drug Product, Aerosol Device and Disposable Dose Packet: (iv) filling
of
Disposable Dose Packets; (v) development of procedures for final release
testing
and testing of Supported Products; (vi) pre-clinical and clinical development
and trials; (vii) regulatory activities relating to the Supported Products,
including without limitation submissions to regulatory authorities; (viii)
medical affairs, such as adverse event reporting and pharmacovigilance.
Discovery shall also be solely responsible for manufacturing and commercializing
the Supported Products.
4.4.3 Responsibilities
of Chrysalis.
(a) In
General.
The
specific activities to be undertaken by Chrysalis in connection with each
Supported Product Development Project and the Supported Products developed
pursuant thereto shall be as set forth in the applicable Project
Plan.
(b) Development
Activities.
Chrysalis shall act as the lead Party for, and shall be principally responsible
for performing, the following development activities with respect to each
Supported Product Development Project: (i) unfilled Disposable Dose Packet
development, including the container closure system, aerosolization capillary
and patient interface; (ii) Aerosol Device development, including the control
unit and pump; and (iii) design and development of filling
equipment.
(c) Consulting
Services.
In
addition to the development activities to be performed by Chrysalis, Chrysalis
shall also provide certain consulting services to Discovery as set forth
in the
Project Plan with respect to each Supported Product. In particular, Chrysalis
shall provide consulting services to Discovery regarding: (i) manufacturing
development for the Aerosol Device and Disposable Dose Packet; (ii) the
development and implementation of quality control specifications and processes
for the Aerosol Device and Disposable Dose Packet; (iii) training and set-up
of
the Aerosol Device and Disposable Dose Packet for preclinical and clinical
studies; (iv) the development of Discovery’s organizational infrastructure to
manage manufacturing of the Supported Products; and (v) troubleshooting
and
corrective measures regarding the Aerosol Device and Disposable Dose Packet.
4.5 Development
Effort.
Each
Party shall use Diligent Development Efforts to
develop
the Supported Products in accordance with the Project Plans therefor and
to
otherwise carry out its responsibilities under this Agreement relating
to such
Supported Products promptly and expeditiously in accordance with all Laws.
Notwithstanding the foregoing, the Parties acknowledge that the development
of
pharmaceutical products is inherently speculative and there is no guarantee
that
the Alliance will be successful in developing any commercially viable Supported
Products, or that the development of any Supported Products will proceed
as
anticipated or in accordance with the Project Plans.
4.6 Development
Milestone.
As soon
as practicable after the Effective Date, Discovery and Chrysalis shall
mutually
agree in writing with respect to each of the Base Supported Product Development
Projects on a particular development milestone related to the development
activities to be performed by Chrysalis in connection therewith (e.g.,
the
delivery of an initial Aerosol Device and related Disposable Dose Packet
design
validated by a prototype) (such event, the “Development
Milestone”)
and
the date by which such Development Milestone should reasonably be achieved
(the
“Milestone
Date”).
Chrysalis shall use Diligent Development Efforts to achieve the Development
Milestone by the Milestone Date. To the extent any delay in achieving such
Development Milestone is caused by Discovery or other factors beyond Chrysalis’
reasonable control, the Milestone Date shall be equitably extended by the
Steering Committee to take into account such delays. If, after taking into
account any such equitable adjustments to the Milestone Date, Chrysalis
fails to
achieve the Development Milestone by such adjusted Milestone Date with
respect
to a Base Supported Product Development
Project
for a particular Base NICU Product or Base Hospital General Product, then
the
royalty payments to Chrysalis hereunder in connection with all NICU Products
or
Hospital General Products, as the case may be, shall be modified as provided
in
Section 8.1(c).
4.7 Skilled
Personnel.
Each
Party shall promptly assign
responsibilities for the various operational aspects of the Alliance, including
without limitation, pursuant to Supported Product Development Projects,
to
portions of their respective organizations which have expertise reasonably
appropriate to perform such functions. Each Party shall be solely responsible
for making all decisions regarding its staffing and personnel.
4.8 Costs.
Except
as otherwise expressly provided in this Agreement, each Party shall be
solely
responsible for all costs incurred by such Party in the performance of
its
obligations in connection with a Supported Product Development Project.
Each
Party shall internally budget for its development costs and shall provide
resources (financial, personnel and otherwise) in accordance with the budgets
set forth in the applicable Project Plans to satisfy their respective
responsibilities under such Project Plan.
4.9 Additional
Licensed Product Opportunities.
4.9.1 Additional
Product Opportunities.
In the
event that Discovery desires to (a) exercise the rights granted
pursuant to
Section 3.1 or (b) develop or commercialize any Licensed Product
other than
the Base NICU Product and the Base Hospital General Product (each, an
“Additional
Product Opportunity”),
then
the following shall apply: (i) should Discovery, in its sole discretion,
develop any such Additional Product Opportunity independently of Chrysalis
(either on its own or with Third Parties), such Additional Product Opportunity
shall be deemed to be a Supported Product for the purposes of determining
the
application of royalties provided for in Section 8.1; (ii) should Discovery,
in
its sole discretion, offer Chrysalis the opportunity to assist with the
development of any such Additional Product Opportunity and (X) should Chrysalis
agree to so assist on the terms and conditions provided for in this Agreement,
then such Additional Product Opportunity shall be deemed to be a Supported
Product for the purposes of determining the application of royalties provided
for in Section 8.1; or (Y) should Chrysalis choose not to assist, then
such
Additional Product Opportunity shall be deemed to be a Independent Product
and
any royalties thereon shall be as provided for in Section 8.2.
4.9.2 Procedure.
Additional Product Opportunities presented by Discovery to the Steering
Committee shall be in a reasonably detailed manner to enable Chrysalis
to
conduct an evaluation of the potential market and collaborative opportunity
with
respect thereto. Reasonably promptly following the presentation of any
such
Additional Product Opportunity, Chrysalis shall make the determination
(a) to
participate in the development of the Licensed Product that is the subject
of
the Additional Product Opportunity (in which case such Licensed Product
will
become a Supported Product Development Project), or (b) not to participate
in
the development of the Licensed Product that is the subject of the Additional
Product Opportunity (in which case such Licensed Product shall constitute
an
Independent Product). In the event Chrysalis fails to notify Discovery
of its
decision to participate in such Additional Product Opportunity within sixty
(60)
days after such presentation, Chrysalis shall be deemed to have elected
not to
participate. In the event Chrysalis elects to participate in the development
of
such Licensed Product, the Parties shall commence a Supported Product
Development Project with respect to such Supported Product as soon as
practicable thereafter. The specific responsibilities of each Party in
connection with the development of such Supported Product shall be as mutually
agreed and set forth in a Project Plan as soon as practicable after each
such
election. The Parties intend that Chrysalis’ and Discovery’s responsibilities
with respect to such Supported Product shall be reasonably comparable to
those
set forth in Sections 4.4.2 and 4.4.3 except as otherwise mutually agreed
taking
into account the particular needs with respect to the development of such
Supported Product.
4.10 Design
Configurations.
Throughout the Term, unless otherwise mutually agreed to by the Parties,
it
shall be a design objective of the Alliance to minimize the number of different
configurations of the Disposable Dose Packets and Aerosol Devices in the
Exclusive Field. Furthermore, the Parties agree that any Aerosol Device
and
Disposable Dose Packet configuration developed for use outside the Exclusive
Field shall be distinct in appearance from those for use with the Licensed
Products and shall not be interchangeable with the Aerosol Device or Disposable
Dose Packet of the Licensed Products. Without limiting the generality of
the
foregoing, neither Party shall offer for sale or sell, or authorize any
Third
Party to offer for sale or sell, any pharmaceutical product (other than
a
Licensed Product) (i) in the Disposable Dose Packet for a Licensed Product,
(ii)
in packaging similar in appearance to the Disposable Dose Packet for a
Licensed
Product, or (iii) in packaging that is interchangeable with the Disposable
Dose
Packet of a Licensed Product for purposes of use in an Aerosol
Device.
ARTICLE
5
GOVERNANCE
AND COMMITTEE STRUCTURE
5.1 General.
The
Alliance shall be governed by the Steering Committee, Alliance Managers,
a
Project Team and such Working Groups as mutually agreed to by the Parties
and as
provided in this Article 5. The
Steering Committee and the Project Team are collectively referred to herein
as
the “Committees.”
5.2 Alliance
Managers.
5.2.1 Appointment
and Roles.
Promptly after the Effective Date, and in any event within thirty (30)
days
thereafter, each of the Parties shall appoint a single individual to act
as that
Party’s alliance manager (the “Alliance
Manager”).
The
role of the Alliance Managers is to act as a single point of contact for
its
respective Party. The Alliance Managers shall have the right to attend
all
Committee meetings and shall support the Committee chairpersons in the
discharge
of their responsibilities. Alliance Managers shall be nonvoting participants
in
such Committee meetings, unless they are also appointed members of such
Committee; provided, however, that an Alliance Manager may bring any matter
to
the attention of any Committee if such Alliance Manager reasonably believes
that
such matter warrants such attention.
5.2.2 Changes
in Alliance Managers.
Each
Party may change its designated Alliance Manager from time to time upon
written
notice to the other Party. Any Alliance Manager may designate a substitute
to
temporarily perform the functions of that Alliance Manager by written notice
to
the other Party. Each Alliance Manager shall be charged with creating and
maintaining a collaborative work environment within and among the Committees.
5.2.3 Additional
Responsibilities of Alliance Mangers.
Each
Alliance Manager, with respect to its Party, shall also: (i) coordinate
the
relevant functional representatives of the Parties in developing and executing
strategies and plans for the Supported Products in an effort to ensure
consistency and efficiency throughout the Territory; (ii) provide a single
point
of communication for seeking consensus both internally within the respective
Parties’ organizations and between the Parties regarding key strategy and plan
issues with respect to the development of the Supported Products; (iii)
plan and
coordinate cooperative efforts and internal and external communications;
and
(iv) take responsibility for ensuring that governance activities, such
as the
conduct of required Committee meetings and production of meeting minutes
occur
as set forth in this Agreement, and that relevant action items resulting
from
such meetings are appropriately carried out or otherwise addressed.
5.3 Steering
Committee.
5.3.1 Formation
and Purpose.
Discovery
and Chrysalis hereby establish a Steering Committee (“Steering
Committee”)
that
shall generally operate by the procedures set forth in Section 5.6. The
Steering
Committee shall have overall
responsibility for the Alliance, including for:
(i) managing
the overall relationship and development activities for the Supported
Products;
(ii) overseeing
the Project Team;
(iii) reviewing,
commenting on, and approving or rejecting Project Plans and updates or
amendments thereto;
(iv) facilitating
the flow of information between the Parties and coordinating the activities
of
the Parties;
(v) attempting
to resolve disputes, if any, with respect to general Alliance matters and
any
disputes referred to the Steering Committee by the Project Team;
(vi) discussing
and making recommendations with respect to Intellectual Property developed
under
the Alliance; and
(vii) performing
such other functions as appropriate to further the purposes of this Agreement
and the Alliance as determined by the Parties.
5.3.2 Membership,
Chairmanship and Meetings.
The
Steering Committee shall be comprised of representatives of each Party
and
initially shall consist of senior representatives from each Party having
the
technical knowledge and decision making authority appropriate for supervising
such Party’s responsibilities under this Agreement. Each Party shall designate
its respective Steering Committee members within thirty (30) days of the
Effective Date. Discovery shall designate the Chairperson of the Steering
Committee. The Steering Committee shall meet at least every six (6) months.
5.4 Project
Team.
5.4.1 Formation
and Purpose.
Reasonably promptly after the Effective Date, Discovery and Chrysalis shall
establish a project team (“Project
Team”)
consisting of representatives designated by each Party. The Project Team
shall
generally operate by the procedures set forth in Section 5.6.
5.4.2 Specific
Responsibilities of the Project Team.
In
furtherance of its responsibility for overseeing, coordinating and expediting
the development of the Supported Products in the Territory, the Project
Team
shall have responsibility for:
(i) developing
Project Plans (including preparation of the applicable budget and related
operational plans) for the development of Licensed Products for manufacture
by
Discovery and technology transfer regarding Licensed Products in coordination
with the Design Review Board;
(ii)
managing
the day-to-day activities related to the operational plans in order to
fulfill
Project Plans;
(iii)
reviewing, amending and updating individual Project Plans on an annual
basis as
well as more frequently as shall be necessary or advisable to take into
account
completion, commencement or cessation of development not then contemplated
by
the Project Plan and submitting such amended or updated Project Plan to
the
Steering Committee for approval;
(iv)
monitoring the progress of development of any Supported Product;
(v)
facilitating the exchange of all development information;
(vi)
working
together to assure a smooth transition from development to Discovery’s
manufacturing and commercialization;
(vii) reporting
on a regular basis to the senior management of each Party as well as to
the
Steering Committee; and
(viii) overseeing
any Working Groups established by the Project Team.
5.4.3 Membership,
Chairmanship and Meetings.
The
Project Team shall be comprised of representatives from each Party possessing
the appropriate experience and expertise and responsible for: Aerosol Device,
Disposable Dose Packet and Drug Product development; quality control/assurance;
regulatory affairs; project management; clinical affairs. The initial members
of
the Project Team for each Party shall be designated promptly following
the
Effective Date. The Project Team shall be jointly chaired by the Parties.
The
Project Team shall meet no less than monthly.
5.5 Working
Groups.
From
time to time, the Committees may establish sub-committees or directed teams
(each, a “Working
Group”)
on an
“as-needed” basis to oversee particular projects or activities. Each such
Working Group shall be constituted and shall operate as the applicable
parent
Committee determines. Each Working Group and its activities shall be subject
to
the oversight, review and approval of, and shall report to, the applicable
parent Committee that established such Working Group. In no event shall
the
authority of the Working Group exceed that specified for the relevant Committee
in this Article
5. The
Parties agree and acknowledge that Alliance Managers shall have access
to all
members of the Working Groups, at reasonable times and places, so as to
be able
to have appropriate oversight and direct interaction with such Working
Group
members.
5.6 General
Committee Membership and Procedures.
5.6.1 Membership
and Meetings.
With
respect to the Parties’ Committee representatives, each representative may serve
on more than one Committee as appropriate in view of such representative’s
expertise. Each Party may replace its Committee representatives at any
time upon
written notice to the other Party. Meetings of any Committee may be held
by
audio or video teleconference with the consent of each Party. All Committee
representatives shall be given prior notice of any Committee meetings.
Each
meeting shall require that representatives from each Party be in attendance
before business may be conducted.
5.6.2 Ad
Hoc
Participants.
Other
employees of each Party (including the Alliance Managers) may attend meetings
of
any Committee as nonvoting participants with the reasonable consent of
the other
Party. In addition, with the consent of both Parties, consultants or advisors
to
a Party may attend Committee meetings as nonvoting observers; provided
that such
Third Party representatives are under obligations of confidentiality and
non-use
applicable to the Confidential Information of each Party and that are at
least
as stringent as those set forth in Article 11. Each Party shall be responsible
for all of its own expenses of participating in any Committee.
5.6.3 Decision-Making.
Each
Party’s representatives on a Committee shall, collectively, have one vote (the
“Party
Vote”)
on all
matters brought before such Committee, which Party Vote shall be determined
by
majority vote of such representatives present at any meeting. Except as
expressly provided in this Section 5.6.3, each Committee shall operate
as to
matters within its jurisdiction by unanimous vote (although the vote of
the
representatives present at a meeting underlying the Party Vote need not
be
unanimous); provided that only the Steering Committee in accordance with
Section
21.15, shall have the authority to amend or modify, or waive compliance
with,
this Agreement.
If a
Committee fails to achieve a unanimous vote with respect to any matter,
such
dispute shall be resolved in accordance with Article 20.
5.6.4 Meeting
Agendas and Minutes.
The
chairperson(s) of each Committee shall be responsible for calling meetings
and
preparing, and circulating an agenda in advance of each meeting of such
Committee. Each Party shall disclose to the chairperson(s) of each Committee
proposed agenda items for a meeting, along with appropriate information
for such
proposed agenda item, at least three (3) Business Days in advance of each
meeting of the applicable Committee; provided that under exigent circumstances
requiring Committee input, a Party may provide its agenda items to the
chairperson(s) of each Committee within a lesser period of time in advance
of
the meeting, or may propose that there not be a specific agenda for a particular
meeting, so long as such other Party consents to such later addition of
such
agenda items or the absence of a specific agenda for such Committee meeting.
The
Alliance Managers, or the particular Committee representatives of each
Party
designated by such Alliance Managers, shall be responsible for, on an alternate
basis, preparing and issuing minutes of each meeting within ten (10) days
of
each Committee meeting; provided, however, that the minutes will not be
finalized until both Parties review and confirm the accuracy of such minutes
in
writing.
5.6.5 Interactions
between Committees and Internal Teams.
The
Parties recognize that while they will establish Committees and Working
Groups
for the purpose of the Alliance, each Party possesses an internal structure
(including various committees, teams and review boards) that will be involved
in
administering such Party’s activities under this Agreement. Each Committee and
Working Group shall establish procedures to facilitate communications between
such Committee or Working Group and the relevant internal committee, team,
or
board of each Party in order to maximize the efficiency of the Alliance,
including by requiring appropriate members of such Committees to be available
at
reasonable times and places and upon reasonable prior notice for making
appropriate oral reports to, and responding to reasonable inquiries from,
the
relevant internal committee, team, or board of each Party.
5.7 Design
Review Board.
Discovery
shall have the right to designate one or more (as agreed by the Parties)
representatives to participate in the design review board established by
Chrysalis to oversee the design of Aerosol Devices for use in the Alliance
(the
“Design
Review Board”).
The
role and voting power of such representative shall be mutually determined
by the
Parties.
ARTICLE
6
COMMERCIALIZATION
6.1 Exclusive
Right to Sell the Licensed Products.
The
Parties agree that during the Term, subject to Discovery’s achievement of the
commercialization milestones and minimums in this Article 6, Discovery
shall
have the exclusive right to market and have marketed, sell and have sold,
and
offer for sale or have offered for sale any Licensed Products.
6.2 Responsibility
For Commercialization Matters.
Discovery
shall have the sole responsibility for all activities associated with the
commercialization of the Licensed Products, including, without limitation,
(a)
preparing, submitting and seeking Marketing Authorizations for the Licensed
Products, (b) sales, advertising and marketing of the Licensed Product,
(c)
scientific and medical affairs, (d) customer service and distribution related
services, such as order taking, shipping, billing, accounts receivable,
returns,
allowance activities and product support; (e) Phase IV Clinical Trials,
(f)
commercial manufacture of the Licensed Product; and (g) branding of the
Licensed
Products.
6.3 Diligent
Commercialization Efforts.
Discovery shall use Diligent Commercialization Efforts to bring the Licensed
Products to market and to market and sell the Licensed Products with a
particular focus on obtaining Marketing Authorizations for and commercializing
Supported Products in the Major Markets. Discovery shall promptly notify
Chrysalis of the receipt of any Marketing Authorization for a Licensed
Product.
6.3.1 Commercialization
Initiation.
With
respect to each Licensed Product, the First Commercial Sale in each country
constituting the Major Markets shall occur within [***]
of
receipt of the relevant Marketing Authorization for such country
for such
Licensed Product. Should Discovery materially fail to achieve any such
commercialization initiation within [***]
of
having received written notice of such failure from Chrysalis [***].
6.3.2 Commercialization
Milestones.
Discovery shall meet certain mutually agreed upon commercialization milestones
(determined in the best faith of the Parties) with respect to minimum sales
levels to be achieved for each Licensed Product in each of the Major Markets.
Such commercialization milestones shall be established no later than
[***]
prior to
the First Commercial Sale of such Licensed Product in each of the Major
Markets
and shall equal Discovery's good faith estimate of total Net Sales for
[***]
after
the First Commercial Sale of such Licensed Product, which estimate shall
be the
same as the estimate used by Discovery for its financial projections and
other
business purposes (the "Estimated
Sales").
The
Estimated Sales forecast for [***]
shall be
reviewed for compliance [***]
prior to
the end of [***],
and may
be reduced for purposes of this calculation of Estimated Sales by up to
[***]
percent
([***]%)
for
[***]
in the
event that Discovery's good faith estimate of such sales has gone down
[***]
percent
([***]%)
or
more. Should Discovery fail to satisfy [***]
percent
([***]%)
of the
Estimated Sales levels (taking into account any adjustment in the [***]
forecast
as provided above) with respect to the subject Licensed Product on a
country-by-country basis in the Major Markets for [***].
ARTICLE
7
REGULATORY
MATTERS
7.1 Responsibility
and Consultation.
Discovery shall be responsible for preparing, submitting, seeking and
maintaining Marketing Authorization for the Licensed Products in the United
States and other jurisdictions in the Territory. Discovery shall consult
with
Chrysalis regarding, and keep Chrysalis regularly and fully informed with
respect to such regulatory matters. Chrysalis shall provide consultant
services
to Discovery regarding Aerosol Device and Disposable Dose Packet related
regulatory matters regarding the Supported Products. Discovery shall provide
Chrysalis with advance notice of all regulatory activities regarding the
Licensed Products that are initiated by Discovery and Chrysalis shall have
the
right to participate in any such activities. Within their respective
responsibilities as outlined in Article 4, the Parties shall cooperate
to
provide each other all reasonable assistance and take all actions reasonably
requested that are necessary to comply with any material requirement of
a Law
applicable to Licensed Products. Each Party shall obtain and maintain all
necessary Regulatory Approvals for the performance of its obligations and
lead
responsibilities under this Agreement and shall take all actions necessary
to
comply with any material requirement of a Law applicable to the performance
of
such Party’s obligations and the exercise of such Party’s rights with respect to
the Licensed Products.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
7.2 Regulatory
Communications.
The
Parties shall cooperate with respect to all interactions and in the drafting
and
review of all submissions to Regulatory Authorities. Each Party shall,
immediately upon receipt of any significant contact with or communication
from
any Regulatory Authority relating to a Licensed Product, but in no event
more
than two (2) Business Days after such receipt or contact, forward a copy
(if in
writing) or description (if oral) of the same to the other Party and respond
to
all reasonable inquiries by the other Party relating thereto. Each Party
shall,
within two (2) Business Days of receipt thereof by such Party, provide
notice to
the other Party of any additional requirements which a Regulatory Authority
may
impose with respect to a Regulatory Approval (including, without limitation,
additional clinical studies) and of all Regulatory Authority inquiries
requiring
a response.
7.3 Meetings.
To the
extent not prohibited by Law, each Party will have an opportunity to participate
in all material meetings between the other Party and a Regulatory Authority
to
the extent that they pertain to the Licensed Products. To the extent
practicable, the Alliance Managers and their designees shall use reasonable
efforts to agree in advance on the scheduling of such meetings and on the
objectives to be accomplished at such meetings, conferences, and discussions
and
the agenda for the meetings, conferences, and discussions with the Regulatory
Authorities. Each Party shall provide the other Party at least five (5)
Business
Days before any such meeting with copies of all documents, correspondence,
and
other materials in its possession, which are relevant to the matters to
be
addressed at any such meeting.
7.4 Sharing
of Information.
In
addition to any other reports required under this Agreement, each Party
shall
provide to the other Party at least once every three Contract Months copies
of
all updated data and information provided by such Party to a Regulatory
Authority in connection with the Licensed Products in the Territory.
7.5 Discovery’s
Right to Audit Certain Third Parties.
Chrysalis shall use reasonable efforts to obtain from Third Parties providing
products or services relating to the Supported Product Development Projects,
the
right for Discovery or its representatives, with reasonable prior written
notice
and during regular business hours, (i) to examine and inspect such Third
Party’s
facilities and (ii) subject to applicable law and any Third Party
confidentiality restrictions or obligations, to examine and inspect data,
documentation, and work products relating to the activities performed by
such
Third Party.
ARTICLE
8
FINANCIAL
PROVISIONS
8.1 Royalties
with Respect to Supported Products.
For
each individual Supported Product:
(a) Royalties
Prior to [***].
Until
[***]
the
First Commercial Sale of such Supported Product, Discovery shall pay royalties
to Chrysalis on Net Sales of Supported Product(s) as follows depending
on the
Combined Net Sales attributable to all of the Supported Products during
such
Contract Year:
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
Combined
Net Sales of Supported Products During Such Contract
Year
|
Royalty
Rate
|
First
$500 million of Combined Net Sales of Supported Products in a
Contract
Year
|
[***]%
of the Net Sales for the particular Supported Product
|
Next
$500 million of Combined Net Sales of Supported Products in a
Contract
Year
|
[***]%
of Net Sales for the particular Supported Product
|
In
excess of $1 billion of Combined Net Sales of Supported Products
in a
Contract Year
|
[***]%
of the Net Sales for the particular Supported Product; subject
to the
exception set forth in Section 8.1(c) below.
|
(b) Royalties
Commencing on [***].
Starting [***]
the
First Commercial Sale of a particular Supported Product, Discovery shall
pay
royalties to Chrysalis on Net Sales of Supported Product as follows depending
on
the Combined Net Sales attributable to all of the Supported Products during
such
Contract Year:
Combined
Net Sales of Supported Products During Such Contract
Year
|
Royalty
Rate
|
First
$500 million of Combined Net Sales of Supported Products in a
Contract
Year
|
[***]%
of Net Sales for the particular Supported Product.
|
In
excess of $500 million of Combined Net Sales of Supported Products
in a
Contract Year
|
[***]%
of Net Sales for the particular Supported Product, subject to
the
exception set forth in Section 8.1(c)
below.
|
For
the
avoidance of doubt, Net Sales with respect to Independent Products shall
not be
taken into account in the calculation of Combined Net Sales with respect
to
Supported Product(s) for purposes of Sections 8.1(a) and 8.1(b).
(c) Reduction
for Failure to Timely Achieve Development Milestone.
In the
event that with respect to a particular Base Supported Product Development
Project, Chrysalis fails
to
achieve the applicable Development Milestone by its Milestone Date, after
any
adjustments in
such
dates pursuant to Section 4.6, then, unless Discovery shall be entitled
to and
shall elect to terminate the Agreement pursuant to Section 17.1.1 or a
Supported
Product Development Project pursuant to Section 17.1.2, [***].
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
8.2 Royalties
with Respect to Independent Products.
For
each individual Independent Product, Discovery shall pay royalties to Chrysalis
on Net Sales of Independent Product(s) in an amount equal to [***]%
of Net
Sales for such Independent Product.
8.3 Prohibition
on Bundling.
Notwithstanding any other provision of this Agreement to the contrary,
Discovery
hereby covenants that it will not include or bundle any Licensed Products
or
components thereof as part of a multiple product offering with any other
products or services if it would result in the price of the Licensed Product
or
any components thereof being discounted from the then-applicable sale price
in
such jurisdiction, nor shall Discovery permit its Affiliates or sublicensees
to
do so, except with the prior written consent of Chrysalis. In the event
any such
bundled sales occur, the Net Sales with respect to such bundled transactions
shall be deemed to be the-then current average Net Sales for the Licensed
Product in such jurisdiction in arms length transactions or in the event
there
are no unbundled transactions, the fair market value of such Net
Sales.
8.4 Fixed
Consideration.
In the
event that Discovery receives any fixed payment, fee or other consideration
from
a Third Party in consideration of any discount, credit or similar allowance
granted to such Third Party in connection with the purchase of any Licensed
Product(s), then Discovery shall pay to Chrysalis a royalty equal to the
product
of (a) such consideration multiplied by (b) the royalty rate applicable
to the
sale of such Licensed Product(s) to such Third Party. Discovery shall report
on
the amount of any such consideration, and the royalty payable thereon in
U.S.
Dollars, in the Royalty Report.
8.5 Treatment
of Partial Product Sales.
In the
event that portions of a Licensed Product are sold separately, (e.g., Aerosol
Device, Disposable Dose Packet, Drug Product) the royalties payable pursuant
to
this Article 8 shall be paid [***].
8.6 Royalty
Reports.
Within
[***]
days
after the end of each Contract Month, Discovery shall deliver to Chrysalis
a
preliminary Royalty Report. [***]
The
Royalty Report shall include at least the following items, separately stated
as
to each of the Licensed Products, as applicable:
(i) the
quantity of each of the Licensed Products (delineated as Aerosol Devices
and
Disposable Dose Packets) invoiced by Discovery and its Affiliates and
sublicensees during such Contract Month and the [***]
amount
therefor;
(ii) the
allowable deductions therefrom and an itemization of each specific deduction
[***];
and
(iii) whether
each such Licensed Product is a Supported Product or Independent
Product;
(iv) the
calculation of royalties, if any, thereon in a manner consistent with the
amounts set forth in the Royalty Report prepared in accordance with this
Section
8.6.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
8.7 Payment
of Estimated and Actual Amounts.
8.7.1 Payment
of Estimated Amounts.
Simultaneous with the issuance of the preliminary Royalty Report, Discovery
shall make payment of estimated amounts due to Chrysalis hereunder with
respect
to such Contract Month (the “Estimated
Amount”).
8.7.2 Quarterly
Reconciliation and True-Up.
Within
[***]
days
following each Contract Quarter, Discovery shall calculate the actual amount
due
to Chrysalis hereunder with respect to the immediately preceding Contract
Quarter (the “Actual Amount”) and provide to Chrysalis a true and accurate
Royalty Report for such Contract Quarter, setting forth the corrected
calculations for such Contract Quarter. If the Estimated Amounts paid to
Chrysalis pursuant to Section 8.7.1 for the three Contract Months comprising
the
immediately preceding Contract Quarter exceeds the Actual Amount for such
Contract Quarter, Discovery shall notify Chrysalis and such excess amount
(the
“Royalty Credit”) shall, at the discretion of Discovery, be available to offset
future royalties payable to Chrysalis by Discovery. If such Actual Amount
exceeds such Estimated Amount, Discovery shall promptly pay such excess
amount
to Chrysalis. [***]
8.8 Pass-Through
Royalties.
Each
Party shall be solely responsible for paying any royalties which may be
due to
Third Parties with respect to such Party’s Intellectual Property.
8.9 Records
and Audits.
8.9.1 Records.
Discovery shall keep, and shall require its Affiliates and sublicensees
to keep,
such records as are necessary to determine accurately the sums due to each
other
under this Agreement. Such records shall be retained by Discovery for the
Term
and for three (3) years thereafter.
8.9.2 Audit.
At the
written request of Chrysalis, with reasonable advance notice, Discovery
shall
make available for inspection, review, and audit, by an internationally
recognized independent certified public accounting firm appointed by Chrysalis
and reasonably acceptable to Discovery, such records of Discovery as may
be
reasonably necessary to verify Discovery’s accounting reports and payments made
or to be made pursuant to this Agreement; provided, however, that such
audits
may not be performed by Chrysalis more than twice per Contract Year in
the
absence of a reasonable basis for concern regarding compliance with the
Agreement or any applicable Laws. If
such
accountants identify a discrepancy, then the appropriate Party shall pay
the
other Party the amount of the discrepancy within thirty (30) days of the
date of
receiving such accountant’s written report, or as otherwise agreed upon by the
Parties, plus, in the event of any underpayment, interest calculated in
accordance with Section 8.12.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
8.9.3 Audit
Confidentiality.
Chrysalis shall cause any accountants selected by it to enter into a
confidentiality agreement acceptable to Discovery obligating such accountants
to
retain all such information in confidence pursuant to such confidentiality
agreement. Such accountants shall not reveal to Chrysalis the details of
its
review, except for such information as is required to be disclosed under
this
Agreement, and such details shall be treated as Confidential Information.
Each
Party agrees to hold in strict confidence all information concerning payments
and reports, and all information learned in the course of any audit or
inspection (and not to make copies of such reports and information), except
to
the extent necessary for such Party to reveal such information in order
to
enforce its rights under this Agreement or if disclosure is required by
Law,
regulation or judicial order.
8.9.4 Costs
of Audits.
Chrysalis shall pay for such inspections, except that in the event the
adjustment shown by such inspection is greater than [***]
percent
([***]%)
of the
amount incurred, Discovery shall pay for such inspection.
8.10 Foreign
Exchange.
For the
purpose of computing the Net Sales for Licensed Products sold in a currency
other than Dollars, such amounts shall be converted into Dollars each Contract
Month in the then standard manner used by Discovery in the preparation
of its
audited financial statements, consistently applied. Such method of currency
conversion used by Discovery shall be a commercially reasonable method
consistent with industry standards, and Discovery shall disclose to Chrysalis
[***]
prior to
First Commercial Sale of a Licensed Product in a country such method of
currency
conversion. Notwithstanding anything herein to the contrary, at Chrysalis’
option, with respect to any particular country in the Territory, Discovery
shall
pay royalties for Licensed Products sold in such country in such country’s local
currency. Discovery shall not change such method of currency conversion
disclosed to Chrysalis pursuant to this Section 8.10 without obtaining
Chrysalis’ prior written consent, such consent not to be unreasonably withheld.
8.11 Manner
of Payments.
All
sums due to Chrysalis under this Agreement shall be payable by electronic
funds
transfer in immediately available funds to such bank account(s) as Chrysalis
shall designate at least two (2) Business Days in advance.
8.12 Late
Payments.
Any
amounts not paid when due under this Agreement shall be subject to interest
from
and including the date payment is due through and including the date upon
which
Chrysalis has collected immediately available funds in an account designated
by
Chrysalis at an annual rate equal to the sum of [***]
percent
([***]%)
plus
the annual prime rate of interest quoted in the Money Rates section of
the East
Coast edition of the Wall
Street Journal
calculated daily on the basis of a 365-day year, or similar reputable data
source, or, if lower, the highest rate permitted under applicable
law.
Notwithstanding the foregoing, any payment of amounts by Discovery representing
the excess of Actual Amount over Estimated Amount, calculated in accordance
with
Section 8.7, shall not be subject to this Section 8.12.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately
filed with the Securities and Exchange Commission.
8.13 Tax
Withholding.
Any
taxes, levies, or other duties (“Taxes”)
paid
or required to be withheld under the appropriate local tax Laws by Discovery
on
account of monies payable to Chrysalis under this Agreement shall be deducted
from the amount of monies otherwise payable to Chrysalis under this Agreement
and paid by Discovery to the proper taxing authority. Discovery shall secure
and
send to Chrysalis within a reasonable period of time proof of any such
Taxes
paid or required to be withheld by Discovery for the benefit of Chrysalis.
The
Parties shall cooperate reasonably with each other to (i) ensure that any
amounts required to be withheld by Discovery are reduced in amount to the
fullest extent permitted by Law
and (ii)
to resolve such other Party’s taxation concerns.
ARTICLE
9
INTELLECTUAL
PROPERTY
9.1 Ownership.
9.1.1 Chrysalis
Intellectual Property.
Chrysalis shall own (i) all Intellectual Property owned or controlled by
Chrysalis relating to the Chrysalis Technology or Licensed Products that
was
existing or conceived prior to the Effective Date, (ii) all Intellectual
Property relating to the Chrysalis Technology or the Licensed Products
developed
by Chrysalis outside of the performance of the Alliance or to which Chrysalis
otherwise obtains rights from a Third Party; (iii) all Inventions conceived,
created and reduced to practice solely by or on behalf of Chrysalis in
the
course of the performance of the Alliance, except Discovery Technology
Improvements; and (iv) all Chrysalis Technology Improvements (collectively,
“Chrysalis
Intellectual Property”).
9.1.2 Discovery
Intellectual Property.
Discovery shall own (i) all Intellectual Property owned or controlled by
Discovery relating to Discovery Technology or the Licensed Products that
was
existing or conceived prior to the Effective Date or is developed by Discovery
outside of the performance of the Alliance, (ii) all Intellectual Property
relating to Discovery Technology or the Licensed Products developed by
Discovery
outside of the performance of the Alliance or exercise of the license granted
hereunder or to which Discovery otherwise obtains rights from a Third Party,
and
(iii) all Inventions conceived, created and reduced to practice solely
by or on
behalf of Discovery in the course of the performance of the Alliance or
exercise
of the license granted hereunder, except Chrysalis Technology Improvements;
and
(iv) all Discovery Technology Improvements (collectively “Discovery
Intellectual Property”).
9.1.3 Joint
Intellectual Property.
Inventions conceived, created and reduced to practice jointly by or on
behalf of
the Parties in the course of the performance of the Alliance or exercise
of the
license granted hereunder shall be jointly owned by the Parties, except
regardless of whether such Inventions were jointly conceived, created or
developed by the Parties, all Chrysalis Technology Improvements shall be
owned
by Chrysalis and all Discovery Technology Improvements shall be owned by
Discovery, as provided in Sections 9.1.1 and 9.1.2. Any Inventions that
are
jointly-owned pursuant to the allocation of Intellectual Property Rights
set
forth in this Section 9.1.3 shall be referred to herein as the “Joint
Inventions.”
9.2 Disclosure,
Assignment, License and Exploitation.
9.2.1 Disclosure.
Each
Party shall cause all personnel conducting work or exercising rights on
its
behalf under the Alliance to, promptly disclose to the other Party all
Intellectual Property in which the other Party has an ownership interest
pursuant to Section 9.1, and to assign any and all right, title
and
interest in all such Inventions and Intellectual Property in accordance
with
this Agreement. Each Party shall maintain records in sufficient detail
and in
good scientific manner appropriate for patent prosecution purposes to properly
reflect all work done and results achieved in conducting its work hereunder,
and
shall respond to reasonable requests of the other Party for information
regarding Intellectual Property in which the other Party has an ownership
interest.
9.2.2 Assignment
and License.
In the
event Chrysalis conceives, creates or reduces to practice any Discovery
Technology Improvements, Chrysalis shall promptly notify Discovery and
Chrysalis
shall assign all right, title and interest in and to such Discovery Technology
Improvements to Discovery. In the event Discovery conceives, creates or
reduces
to practice any Chrysalis Technology Improvements, Discovery shall promptly
notify Chrysalis of such Invention and Discovery shall assign all right,
title
and interest in and to such Chrysalis Technology Improvements to Chrysalis,
however, such Chrysalis Technology Improvements are included in the Intellectual
Property licensed to Discovery pursuant to Section 3.1.
9.2.3 Exploitation
of Intellectual Property.
To the
extent permitted by Law, except as expressly provided in this Section 9.2.3
below, Chrysalis agrees not to exploit the Chrysalis Intellectual Property
or
its ownership interest in the Joint Intellectual Property in a pharmaceutical
product for the Target Populations for the Target Indications in a manner
that
competes with a Licensed Product(s) in the Hospital Setting for such Target
Indications. Notwithstanding the foregoing, this Section 9.2.3 shall not
limit
Chrysalis’ ability to exploit any Inventions conceived, created and reduced to
practice solely by or on behalf of Chrysalis after the Effective Date,
except
Discovery Technology Improvements. To the extent permitted by Law, Discovery
agrees not to exploit its ownership interest in the Joint Intellectual
Property
in a pharmaceutical product for the Target Populations for the Target
Indications in a manner that competes with a Licensed Product(s) in the
Hospital
Setting for such Target Indications.
9.3 Agreement
with Personnel.
Each
Party shall have valid and enforceable written agreements with all personnel
conducting work on its behalf under the Alliance containing a nondisclosure
obligation comparable in scope to Article 11 and giving the other Party
all
rights and authority necessary to effectuate the provisions of this Article
9.
Each Party shall provide copies of these agreements to the other Party
upon the
other Party’s request as allowed by each Party’s internal personnel
policies.
9.4 Prosecution
of Patents.
9.4.1 Discovery
and Chrysalis Patent Filings.
Discovery and Chrysalis each shall use commercially reasonable efforts
to
diligently prosecute their respective Patents claiming a Licensed Product
in the
Territory. As soon as practicable prior to any contemplated filing, the
Party
filing a Patent claiming a Licensed Product shall submit a substantially
completed draft of the applicable Patent to the other Party for its review
and
comment, which comments shall be considered in good faith. Within forty-five
(45) days of a Party’s receipt of an allowance or grant of a Patent, the Party
prosecuting the Patent shall inform the other Party of such allowance or
grant,
and provide the other Party with a copy of the allowed or granted Patent
claims
thereof. If the other Party determines that filing one or more continuing
or
divisional Patents is necessary to cover such Party’s rights or commercial
interests, then the prosecuting Party shall file such one or more continuing
or
divisional patents in a timely manner prior to the expiration of any period
for
making such filings.
9.4.2 Joint
Patent Filings.
The
Parties shall refer any Joint Inventions to the Steering Committee to allow
the
Steering Committee to determine which Party should be responsible for filing,
prosecuting, and maintaining any Joint Patent related to such Joint Invention
based on a good faith determination of the relative contributions of the
Parties
to the Joint Inventions, the relative level of interest of the Parties
in the
Joint Inventions and the relative extent to which the Licensed Product
relating
to such Joint Patents is being developed or commercialized. The Steering
Committee may decide not to file a Joint Patent for any Joint Invention.
The
Party determined to be responsible for a Joint Patent shall use commercially
reasonable efforts to diligently prosecute that Patent in the Territory.
As soon
as practicable prior to any contemplated filing, the Party responsible
hereunder
for such activities shall submit a substantially completed draft of the
applicable Joint Patent or Joint Patents to the other Party for its approval,
which shall not be unreasonably withheld. Within forty-five (45) days of
the
allowance or grant of a Joint Patent, the Party responsible hereunder shall
inform the other Party of such allowance or grant, and provide the other
Party
with a copy of the allowed or granted Patent. If the other Party determines
that
filing one or more continuing or divisional Patents is necessary to cover
the
Parties’ rights or commercial interests in Joint Inventions, then the
responsible Party shall file such one or more continuing or divisional
patents
in a timely manner prior to the expiration of any period for making such
filings.
9.4.3 Patent
Prosecution Costs.
Each
Party shall bear its own costs to file, prosecute and maintain its Patents,
or
Joint Patents for which it is responsible, in the Territory (including,
without
limitation, patent term extension).
9.4.4 Abandonment
of Prosecution.
Each
Party shall notify the other Party in the event it is unable for any reason
to
meet its obligations under this Article 9 with respect to any Patents covering
the Licensed Products. Such notification shall be given within a reasonable
period prior to the date on which such Patents will lapse or become abandoned.
The Party receiving any notification hereunder shall then have the option,
exercisable upon written notification to the Party that delivered such
notification, to assume full responsibility, at its discretion and its
sole cost
and expense, for prosecution or maintenance of the affected Patents in
such
country or countries in the Territory.
9.5 Patent
Term Extensions.
Each
Party shall have the right to request that the other Party file all applications
and take all actions necessary to obtain patent extension pursuant to 35
U.S.C.
§ 156 or like foreign statutes for the respective Parties’ Patents and the Joint
Patents in the Territory. If the filing Party declines to pursue such patent
term extensions, then as permitted by law, the other Party shall have the
right
(at its cost and expense) on behalf of the filing Party to file, or direct
the
filing of, all such applications and take all such actions necessary to
obtain
such patent term extensions. Each Party agrees to sign such further documents
and take such further actions as may be requested by the other Party in
this
regard.
9.6 Third
Party Infringement.
9.6.1 Suits
for Infringement.
If
Discovery or Chrysalis becomes aware of infringement of any Patent included
in
the Discovery Patents or the Chrysalis Patents by a Third Party in the
Territory, such Party shall promptly notify the other Party in writing
to that
effect and provide a summary of the relevant facts and circumstances known
to
such Party relating to such infringement (“Infringement
Notice”).
Each
Party shall have the right, at its sole discretion and expense, on its
own
behalf, to institute, prosecute, and control any action or proceeding to
restrain infringement of any of its Patents. A Party instituting suit shall
have
control of such suit and all negotiations for its settlement or compromise;
provided however, that the instituting Party shall not settle or compromise
any
such suit or enter into any consent order for the settlement or compromise
thereof which would materially adversely affect the Intellectual Property
rights
with respect to a Licensed Product without the prior written consent of
the
other Party, which consent shall not be unreasonably withheld, conditioned,
or
delayed.
9.6.2 Step-in
Right.
If,
prior to the expiration of three (3) months from said Infringement Notice,
the
Party whose Patents are alleged to be infringed has not obtained a
discontinuance of an alleged infringement by a Third Party or brought an
infringement action or proceeding or otherwise taken appropriate action
to abate
such infringement, such Party shall notify the other Party at any time
prior
thereto of its intention not to bring suit against an alleged infringer.
Upon
such notice and if such infringement is reasonably likely to materially
adversely affect a Licensed Product in the Territory, then, and in those
events
only, the other Party shall have the right, but not the obligation, at
its sole
expense to institute, prosecute, and control any action or proceeding to
restrain such infringement. Each Party agrees to be joined as a party if
necessary to prosecute the action or proceeding and shall provide all reasonable
cooperation, including any necessary use of its name, required to prosecute
such
litigation. The other Party shall have control of any such suit and all
negotiations for its settlement or compromise; provided, however, that
the other
Party shall not settle or compromise any such suit or enter into any consent
order for the settlement or compromise thereof without the prior written
consent
of the patentee Party, which consent shall not be unreasonably withheld,
conditioned, or delayed.
9.6.3 Allocation
of Recovery.
All
damages, settlements and rewards made or obtained in connection with any
suit or
other legal proceeding under this Section 9.6 shall be shared among the
parties
as follows: [***]
9.6.4 Declaratory
Actions and Counterclaims.
In the
event that an action alleging invalidity or non-infringement of any of
the
Discovery Patents or Chrysalis Patents is brought against Discovery or
Chrysalis, the Party defending such action or counterclaim, at its sole
discretion, shall have the right, within thirty (30) days after the commencement
of such action, to take or regain control of the action at its own expense.
If
the defending Party determines
not to exercise this right, the other Party may take over or remain as
lead
counsel for the action at that Party’s sole discretion. Any recovery obtained
from such litigation, proceeding or settlement shall be shared in accordance
with Section 9.6.3.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
9.7 Infringement
of Third Party Rights.
9.7.1 Infringement
Claims.
With
respect to any and all claims instituted by Third Parties for patent
infringement involving the manufacture, use, offer for sale, or sale of
a
Licensed Product in the Territory during the Term, the Party named as defendant
shall promptly notify the other Party of such claim, and the defending
Party
shall have the right, at its sole discretion and expense, to defend and
control
any action or proceeding with respect to such claim. The other Party agrees
to
be joined as a Party if necessary to defend the action or proceeding and
shall
provide reasonable cooperation, including any necessary use of its name,
required to defend such litigation. The defending Party shall have sole
control
of any such suit and all negotiations for its settlement or compromise;
provided, however, that the defending Party shall not settle or compromise
any
such suit or enter into any consent order for the settlement or compromise
thereof without the prior written consent of the other Party if such settlement
would materially adversely affect the other Party’s rights or impose any
obligation on the other Party, which consent shall not be unreasonably
withheld,
conditioned, or delayed.
9.7.2 Step-in
Right.
If,
prior to the expiration of three (3) months from said claim being brought,
or
such sooner period as may be necessary to appropriately respond to said
claim,
the defending Party has not elected to defend such action or proceeding,
or if
the defending Party shall notify the other Party at any time prior thereto
of
its intention not to defend such action or proceeding, then, and in those
events
only, the other Party shall have the right, but not be obligated, at its
own
expense to defend and control any action or proceeding. Such other Party
shall
have sole control of any such suit and all negotiations for its settlement
or
compromise; provided, however, that the other Party shall not settle or
compromise any such suit or enter into any consent order for the settlement
or
compromise thereof without the prior written consent of the original defending
Party, which consent shall not be unreasonably withheld, conditioned, or
delayed.
9.7.3 Notice
of Certification.
Discovery and Chrysalis each shall immediately give notice to the other
of any
certification filed under the U.S. “Drug Price Competition and Patent Term
Restoration Act of 1984” claiming that Discovery Patents, Chrysalis Patents or
the Joint Patents are invalid or that any infringement will not arise from
the
manufacture, use, or sale of any Licensed Product by a Third Party. If
a Party
decides not to bring infringement proceedings against the entity making
such a
certification, that Party shall give notice to the other Party of its decision
not to bring suit within twenty-one (21) days after receipt of notice of
such
certification. The other Party may then, but is not required to, bring
suit
against the party that filed the certification. Any suit by Discovery or
Chrysalis shall either be in the name of Discovery or in the name of Chrysalis,
or jointly in the name of Discovery and Chrysalis, as may be required by
Law.
For this purpose, the Party not bringing suit shall execute such legal
papers
necessary for the prosecution of such suit as may be reasonably requested
by the
Party bringing suit.
ARTICLE
10
RIGHT
OF FIRST ACCESS TO CERTAIN ADDITIONAL
OPPORTUNITIES
10.1 First
Access Products.
During
the five year period commencing on the Effective Date and ending on the
fifth
anniversary thereof, each Party shall provide the other with the first
option to
negotiate described in this Article 10 (the “Right
of First Access”)
with
respect to all First Access Products. A “First
Access Product”
shall
mean a combination drug-device product comprised of an aerosolization device
and
an active pharmaceutical compound (other than a Pulmonary Surfactant) which
pharmaceutical product (a) is intended for the treatment of a Respiratory
Indication in the Hospital Setting in the Target Populations and (b) is
a
pharmaceutical compound that such Party has the right to market and sell
and
there is no restriction as to the use of Discovery or Chrysalis, as applicable,
as a development or commercialization partner for combination drug-device
products containing such pharmaceutical compound.
10.2 Provision
of Right of First Access.
Each
Party shall provide to the other the Right of First Access within sixty
(60)
days of such Party’s completion of a phase 2 clinical trial for FDA submission
(constituting a study of a candidate drug in the target patient population
of a
sufficient number and sufficient length of time whereby adequate safety
data is
provided and there is a clear indication of dosage effects with respect
to
efficacy as defined in the study protocol for such drug candidate). Such
completion date shall be referred to as the “Phase
2 Completion Point”.
10.3 First
Access Product Presentation. Within sixty (60) days after the Phase 2 Completion
Point for a First Access Product, the
Party
which developed the First Access Product shall, in compliance with any
Third
Party confidentiality restrictions, present the opportunity for the treatment
of
the specified indication in the Target Population to the other Party in
a
reasonably detailed manner to enable the receiving Party to conduct an
evaluation of the potential market and collaborative opportunity with respect
thereto (the “First
Access Product Presentation”).
10.4 Negotiation
of First Access Product Arrangements.
Within
thirty (30) days from the date of the First Access Product Presentation,
the
receiving Party shall notify the presenting Party in writing whether it
desires
to enter into negotiations with respect to a potential commercial arrangement
regarding the development and/or commercialization of such First Access
Product
for the treatment of a Respiratory Indication in the Hospital Setting.
In the
event the receiving Party notifies the presenting Party of its desire to
negotiate a possible commercial arrangement during such thirty (30) day
period,
the Parties shall promptly commence such negotiations. In the event the
receiving Party fails to notify the presenting Party of its desire to negotiate
a possible commercial arrangement during such thirty (30) day period, or
the
Parties fail, despite such negotiations to enter into definitive agreements
within sixty (60) days of the date of the initiation of such negotiations,
the
presenting Party shall be entitled to negotiate and enter into commercial
arrangements with Third Parties relating to the First Access Product for
the
specified indication in the Target Population, provided that any such
arrangements with Third Parties shall not be on terms that are, in substance,
more favorable than those offered to the receiving Party, taking into account
the relative merits of the respective technologies and the development
and
commercialization capabilities of the prospective partners.
ARTICLE
11
CONFIDENTIAL
INFORMATION
11.1 Use
of
Confidential Information.
A Party
receiving Confidential Information (the “Receiving
Party”)
from
the other Party (the “Disclosing
Party”)
shall
keep all such Confidential Information with the same degree of care it
maintains
the confidentiality of its own confidential information, but in no event
less
than a reasonable degree
of
care. Neither Party shall use such Confidential Information for any purpose
other than in performance of this Agreement,
and
shall
not disclose the same to any Person other than to its Affiliates and such
of its
and their employees or agents who have a need to know such Confidential
Information to implement the terms of this Agreement, and who are subject
to a
nondisclosure obligation comparable in scope to this Article 11. Each Party
shall advise any employee or agent who receives such Confidential Information
of
the confidential nature thereof and of the obligations contained in this
Agreement relating thereto, and such Party shall ensure that all such employees
and agents comply with such obligations as if they had been a Party hereto.
Upon
termination of this Agreement, each Party shall use commercially reasonable
efforts to return or destroy all documents, tapes or other media containing
Confidential Information of the Disclosing Party that remains in such Party’s or
its agents’ or employees’ possession, except that each Party may keep one (1)
copy of the Confidential Information solely for archival purposes. Such
archival
copy shall be deemed to be the property of the Disclosing Party, and shall
continue to be subject to the provisions of this Article 11.
Notwithstanding anything to the contrary in this Agreement, Confidential
Information shall not include any information or materials that the Receiving
Party can demonstrate by documentary evidence:
(i) were
already known to the Receiving Party (other than under an obligation of
confidentiality), at the time of disclosure by the Disclosing
Party;
(ii) were
generally available to the public or otherwise part of the public domain
at the
time of its disclosure to the Receiving Party;
(iii) became
generally available to the public or otherwise part of the public domain
after
its disclosure or development, as the case may be, and other than through
any
act or omission of a Party in breach of such Party’s confidentiality obligations
under this Agreement;
(iv) were
disclosed to a Party, other than under an obligation of confidentiality,
by a
Third Party who had no obligation to the Disclosing Party not to disclose
such
information to others; or
(v) were
independently discovered or developed by or on behalf of the Receiving
Party
without the use of the Confidential Information belonging to the other
Party.
11.2 Permitted
Disclosure and Use.
Notwithstanding anything to the contrary in this Agreement, in the event
that
the Receiving Party or any of its directors, officers, employees, agents
and
advisors and their representatives deems it necessary or are requested
or
required (by oral questions, deposition, interrogatories, requests for
information or documents, subpoena, civil investigative demand or other
legal
process by a court or other governmental authority, or by any Regulatory
Authority to obtain Regulatory Approval of a Licensed Product) to disclose
all
or any part of any Confidential Information, the Receiving Party will provide
the Disclosing Party with prompt notice of such request or requirement
(which
notice shall be reasonably in advance of such requested or required disclosure),
as well as notice of the terms and circumstances surrounding such request
or
requirement, so that the Disclosing Party may seek an appropriate protective
order or waive compliance with the provisions of this Agreement. In such
case,
the Receiving Party shall consult with the Disclosing Party with respect
to the
advisability of pursuing any such order or other legal action or available
steps
to resist or narrow such request or requirement. If, failing the entry
of a
protective order or the receipt of a waiver hereunder, the Receiving Party
is,
in the opinion of counsel satisfactory to the Disclosing Party and its
counsel,
legally compelled to disclose any Confidential Information, the Receiving
Party
may disclose that portion of the Confidential Information which its counsel
advises the Receiving Party that the Receiving Party is legally compelled
to
disclose. In any event, the Receiving Party will use reasonable efforts
to
obtain and will not oppose action by the Disclosing Party to obtain, an
appropriate protective order or other reliable assurance that confidential
treatment will be afforded the disclosure of such Confidential Information.
The
Receiving Party will use best efforts to cause its directors, officers,
employees, affiliates, agents and advisors and their representatives to
comply
with the terms of this Section. A Receiving Party may disclose Confidential
Information belonging to a Disclosing Party to the extent such disclosure
is
reasonably necessary to enforce the provisions of this Agreement.
11.3 Disclosure
for SEC Filings.
Notwithstanding anything to the contrary in this Agreement, the Parties
expressly acknowledge that Discovery may file a copy of this Agreement
with the
Securities and Exchange Commission (the “SEC”)
in any
of its SEC reports and filings, as well as incorporate them by reference
into
other SEC filings. Discovery shall request confidential treatment of sensitive
terms hereof to the extent such confidential treatment is reasonably available
to Discovery under the prevailing circumstances. Discovery shall coordinate
in
advance with Chrysalis with regard to the terms of this Agreement, for
which
Discovery shall seek to be redacted in any such SEC filings, and Discovery
shall
use reasonable efforts to seek confidential treatment for such mutually
agreed
terms and terms reasonably requested by Chrysalis; provided, however, that
each
Party shall retain ultimate control and responsibility for their respective
disclosures to the SEC and the public generally.
To the
extent permitted by Law, Discovery shall use reasonable efforts to provide
Chrysalis reasonable advance notice of any SEC filing related to this Agreement
which differs materially from prior filings.
11.4 Publications.
Subject
to any Third Party rights existing as of the Effective Date, each Party
shall
submit to the other Party for review and approval all proposed academic,
scientific and medical publications and public presentations relating to
a
Licensed Product or any research or development activities conducted as
part of
the Alliance for review in connection with preservation of Patents, and
trade
secrets and/or to determine whether Confidential Information should be
modified
or deleted from the proposed publication or public presentation. Written
copies
of such proposed publications and presentations shall be submitted to the
non-publishing Party no later than sixty (60) days before submission for
publication or presentation and the non-publishing Party shall provide
its
comments with respect to such publications and presentations within ten
(10)
Business Days of its receipt of such written copy. The review period may
be
extended for an additional thirty (30) days if the non-publishing Party
can
demonstrate a reasonable need for such extension including the preparation
and
filing of patent applications. By written agreement, this period may be
further
extended. The Parties will each comply with standard academic practice
regarding
authorship of scientific publications and recognition of contribution of
other
Persons in any publications relating to a Licensed Product or any research
or
development activities under this Agreement.
11.5 Public
Announcements.
Subject
to Section 11.2 and Section 11.3, neither Party will make any public
announcement of any information regarding this Agreement, the Licensed
Products
or any research or development activities under this Agreement without
the prior
written approval of the other Party, provided however that each Party may
disclose (i) the general stage of development, commercialization and
manufacturing at any given time during the course of the Alliance, except
to the
extent that any such information constitutes Confidential Information,
(ii) any
information required by Law, and (iii) any other information that has been
previously approved for disclosure by the other Party, without further
approval
from the other Party hereunder.
The
Parties agree and acknowledge that Discovery may, at its sole discretion,
subject to its compliance with this Article 11, file a Current Report on
Form
8-K with the SEC to announce the filing of the press release and file it
as an
exhibit thereto, as well as to incorporate it by reference into other SEC
filings.
At each
Party’s option, public releases by the other Party concerning the Alliance,
including press releases, technical publications, regulatory filings, seminar
and conference speeches and posters, interviews, videos and other public
statements concerning the Alliance shall mention the other Party as a
development partner.
11.6 Survival.
The
obligations and prohibitions contained in this Article 11 shall survive
the
expiration or termination of this Agreement.
ARTICLE
12
REPRESENTATIONS,
WARRANTIES AND COVENANTS
12.1 Mutual
Representations and Warranties.
Each
Party hereby represents, warrants and covenants to the other Party that
as of
the Effective Date:
12.1.1 Organization;
Authority.
It is
duly organized, validly existing and in good standing under the laws of
the
jurisdiction of its incorporation, has full right, corporate power and
authority
to enter into this Agreement, to perform its obligations under this Agreement,
to grant the licenses granted by such Party pursuant to this Agreement
and to
carry out the provisions hereof.
12.1.2 Consents.
Except
for any Regulatory Approvals necessary for the development, manufacture,
or
commercialization of a Licensed Product, all necessary consents, approvals,
orders, permits and authorizations of all government authorities and Regulatory
Authorities and other Persons or Third Parties required to be obtained
by it as
of the Effective Date in connection with the execution, delivery, and
performance of this Agreement have been obtained.
12.1.3 No
Conflict.
The
execution and delivery of this Agreement by such Party, the performance
of such
Party’s obligations hereunder, and the rights, licenses and sublicenses to be
granted by such Party pursuant to this Agreement, (i) do not conflict with,
violate or constitute a breach or default under any requirement of Laws
or
regulations existing as of the Effective Date and applicable to such Party
or
under any instrument, judgment, order, writ, decree, contract of such Party
or
any of its Affiliates existing as of the Effective Date; (ii) do not give
rise
to any event that results in the creation of any lien, charge or encumbrance
upon any assets of such Party or the suspension, revocation, impairment,
forfeiture or non-renewal of any material permit, license, authorization
or
approval that applies to such Party, its business or operations or any
of its
assets or properties; or (iii) conflict with any rights granted by such
Party to
any Third Party or breach any obligation that such Party has to any Third
Party.
12.1.4 Enforceability.
This
Agreement is a legal and valid obligation binding upon it and is enforceable
against it in accordance with its terms, subject to and limited by: (i)
applicable bankruptcy, insolvency, reorganization, moratorium, and other
laws
generally applicable to creditors’ rights; and (ii) judicial discretion in the
availability of equitable relief.
12.1.5 Regulatory.
There
are no investigations, inquiries, actions or other proceedings pending
before
or, to such Party’s knowledge, threatened, by any Regulatory Authority or other
government agency with respect to any Licensed Products (or components
thereof)
or any facility where such Licensed Products (or components thereof) are
manufactured, and such Party has not received written notice threatening
any
such investigation.
12.2 Intellectual
Property.
Discovery represents, warrants, and covenants to Chrysalis that as of the
Effective Date with respect to the Discovery Intellectual Property and,
except
with regard to Chrysalis’ intellectual property rights in the name “Aria,”
Chrysalis represents, warrants, and covenants to Discovery that as of the
Effective Date with respect to the Chrysalis Intellectual Property:
(i) It
(a)
holds good title to and is the legal and beneficial owner of, or (b) is
the
licensee of, such Intellectual Property free and clear of any lien, mortgage,
security interest, license, right, pledge, restriction on transferability,
defect of title or other claim, charge, or encumbrance of any nature whatsoever
on or affecting any property or property interest and no Third Party has
any
right, title, or interest in or to such Intellectual Property.
(ii) To
its
knowledge, the Patents included in such Intellectual Property are valid
and
enforceable in the Major Markets and there have been no, and such Party
has no
reason to believe that there will be any, inventorship challenges with
respect
to any of such Patents.
(iii) There
are
no infringement proceedings, actions, suits or complaints pending against
nor
any outstanding injunctions, judgments, orders, decrees, rulings or other
charges against such Party relating to such Intellectual Property.
(iv) It
has
not received any form of notice from a third party of infringement of Third
Party Patent rights that may affect the making, using or selling of Licensed
Products; and to its knowledge (a) the manufacture, development and
commercialization of the Licensed Products will not infringe the Patents
of any
Third Party and (b) there are no Third Party patent applications pending
which,
if issued, would materially adversely affect the ability to make, use or
sell
the Licensed Products.
(v) It
has
not granted any third party any license, covenant not to sue, options,
or other
right with respect to such Intellectual Property that would impact its
ability
to enforce such Intellectual Property. There are no existing agreements,
options, commitments, or rights with, of, or to any Person to acquire or
obtain
any rights with respect to the Intellectual Property that are inconsistent
with
the rights granted herein.
(vi) Each
agreement pursuant to which a Third Party has granted, assigned or otherwise
transferred rights with respect to such Intellectual Property are in full
force
and effect, and no Party to such agreements is in breach or default thereunder,
and the execution and performance of this Agreement will not result in
a breach
or default thereunder. It has provided a true and complete copy of each
such
Third Party agreement to which it is a party to the other Party.
12.3 No
Adverse Effects.
Discovery represents, warrants and covenants to Chrysalis that as of the
Effective Date, the studies of Pulmonary Surfactants conducted by Discovery
prior to the Effective Date have not shown any adverse effects or toxicity
of
the Pulmonary Surfactant in humans that could reasonably be anticipated
to
frustrate the purposes of this Alliance, and as of the Effective Date,
Discovery
has not been informed of any such adverse effects or toxicity.
ARTICLE
13
ADDITIONAL
COVENANTS
13.1 Compliance
with Laws.
Each
Party
shall perform its responsibilities in a good scientific manner in accordance
with the terms of this Agreement and in compliance in all material respects
with
the requirements of Laws.
13.2 Cooperation.
The
Parties agree that maintaining effective and open communication between
the
Parties on matters relating to the Alliance is important to the success
of the
Alliance. Upon reasonably advance notice, each Party shall make its employees
and consultants reasonably available to consult with the other Party on
any
aspect of the relationship, including regulatory, scientific, technical
and
clinical testing issues and shall provide the other Party reasonable access
to
materials relating to the development of Licensed Products.
13.3 Sharing
of Information.
Subject
to applicable Law and privileges and obligations of confidentiality, the
Parties
agree to provide the other Party, upon such other Party’s reasonable request,
copies or access to all data, documentation and work products, including
Clinical Trials, relating to any Licensed Product.
ARTICLE
14
DISCLAIMERS
AND LIMITATION OF LIABILITY
14.1 Disclaimer
of Warranties.
EXCEPT
AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES
ANY
REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE,
CONCERNING THE DEVELOPMENT, COMMERCIALIZATION, MARKETING, OR SALE OF ANY
PRODUCT
INCLUDING THE SUCCESS OR POTENTIAL SUCCESS THEREOF. EXCEPT AS EXPRESSLY
SET
FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS,
WARRANTIES AND AGREEMENTS OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
THE
PARTIES UNDERSTAND THAT THE LICENSED PRODUCTS ARE THE SUBJECT OF ONGOING
CLINICAL RESEARCH AND DEVELOPMENT AND THAT NEITHER PARTY CAN ASSURE THE
SAFETY
OR USEFULNESS OF LICENSED PRODUCTS. NEITHER PARTY MAKES ANY REPRESENTATION
OR
WARRANTY EXCEPT AS SET FORTH IN THIS ARTICLE 14 CONCERNING ITS PATENT RIGHTS
OR
KNOW-HOW, INCLUDING THE VALIDITY OR SCOPE OF ITS PATENT RIGHTS OR THAT
THE
MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT WILL NOT INFRINGE THE
PATENT
RIGHTS OF THIRD PARTIES.
14.2 Limitation
of Liability.
IN NO
EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY OF ITS PERSONNEL
FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY
DAMAGES (INCLUDING, LOST PROFITS, BUSINESS, OR GOODWILL) SUFFERED OR INCURRED
BY
SUCH OTHER PARTY OR ITS AFFILIATES AND THEIR RESPECTIVE PERSONNEL IN CONNECTION
WITH A BREACH OR ALLEGED BREACH OF THIS AGREEMENT EXCEPT WHERE ATTRIBUTABLE
TO A
WILLFUL OR INTENTIONAL BREACH OF THIS AGREEMENT. NOTHING IN THIS SECTION
14.2 IS
INTENDED TO, NOR SHALL, LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS UNDER THIS
ARTICLE 14, OR ANY REMEDIES OR DAMAGES AVAILABLE FOR BREACHES OF CONFIDENTIALITY
OBLIGATIONS IN ARTICLE 11.
ARTICLE
15
INDEMNIFICATION;
INSURANCE
15.1 Indemnification.
15.1.1 Obligations
of the Parties.
Each
of
the Parties shall defend, indemnify and hold harmless the other Party,
its
Affiliates and its and their respective directors, officers, employees,
consultants, contractors, representatives and agents (collectively, the
“Indemnified
Parties”)
from
and against any and all losses, costs, damages, fees, liabilities, or expenses
(including reasonable attorneys’ fees and expenses) (collectively, “Losses”)
incurred in connection with any Third Party claim, action or proceeding
(a
“Third Party Claim”) arising out of or related to:
(i) any
material breach by the indemnifying Party of any of its representations,
warranties, covenants or obligations pursuant to this Agreement;
(ii) any
negligence, recklessness, willful misconduct or wrongful intentional acts
or
omissions of the indemnifying Party, its Affiliates, or their officers,
directors, employees, contractors, consultants, agents, representatives,
or
sublicensees in the exercise of any of the indemnifying Party’s rights or the
performance of any of the indemnifying Party’s obligations under this Agreement,
provided, however, that each Party maintains the right to seek indemnification
pursuant to this Section 15.1.1 with respect to strict liability claims
by Third
Parties to the extent that the other Party’s negligence resulted in such strict
liability claim; and
(iii) intellectual
property infringement and trade secret misappropriation liability resulting
from
acts or omissions by the indemnifying Party, its Affiliates and sublicensees
relating to the development, manufacture, or commercialization of any Licensed
Product.
15.1.2 Certain
Product Liability Claims.
In
addition to the indemnity set forth in Section 15.1.1 above, Discovery
shall
defend, indemnify and hold harmless Chrysalis, its Affiliates and its and
their
respective directors, officers, employees, consultants, contractors,
representatives and agents from and against any and all Losses incurred
in
connection with any Third Party Claims arising out of or relating to the
commercialization, marketing, sale, use, handling, manufacture and/or storage
of
any Licensed Product, including any claims that involve death or bodily
injury
(or allegations thereof) to any individual, except to the extent such Losses
are
due to matters for which Chrysalis is required to provide indemnification
pursuant to Section 15.1.1.
15.1.3 Complete
Indemnification.
As the
Parties intend complete indemnification, all direct out of pocket costs
and
expenses reasonably incurred by an Indemnitee in connection with enforcement
of
Section 15.1 shall also be reimbursed by the Indemnitor.
15.2 Indemnification
Procedures.
15.2.1 Notification.
In the
case of a Third Party Claim as to which a Party may be obligated to provide
indemnification pursuant to this Agreement (the “Indemnitor”),
such
Indemnified Party seeking indemnification hereunder (“Indemnitee”)
will
notify the Indemnitor in writing of the Third Party Claim (and specifying
in
reasonable detail the factual basis for the Third Party Claim and to the
extent
known, the amount of the Third Party Claim) reasonably promptly after becoming
aware of such Third Party Claim; provided, however, that failure to give
such
notification will not affect the indemnification provided hereunder except
to
the extent the Indemnitor shall have been actually prejudiced as a result
of
such failure.
15.2.2 Assumption
of Defense.
If a
Third Party Claim is made against an Indemnitee, the Indemnitor will be
entitled, within one hundred twenty (120) days after receipt of written
notice
from the Indemnitee of the commencement or assertion of any such Third
Party
Claim, to assume the defense thereof (at the expense of the Indemnitor)
with
counsel selected by the Indemnitor and reasonably satisfactory to the
Indemnitee, for so long as the Indemnitor is conducting a good faith and
diligent defense. Should the Indemnitor so elect to assume the defense
of a
Third Party Claim, the Indemnitor will not be liable to the Indemnitee
for any
legal or other expenses subsequently incurred by the Indemnitee in connection
with the defense thereof; provided, however, that if in the opinion of
counsel,
such counsel and opinion being satisfactory to Indemnitor and its counsel,
a
conflict of interest exists between the Indemnitor and an Indemnitee in
respect
of such claim, such Indemnitee shall have the right to employ separate
counsel
(which shall be reasonably satisfactory to the Indemnitor) to represent
such
Indemnitee with respect to the matters as to which a conflict of interest
exists
and in that event, the reasonable fees and expenses of such separate counsel
shall be paid by such Indemnitor; provided further, that the Indemnitor
shall
only be responsible for the reasonable fees and expenses of one (1) separate
counsel for such Indemnitee. If the Indemnitor assumes the defense of any
Third
Party Claim, the Indemnitee shall have the right to participate in the
defense
thereof and to employ counsel, at its own expense, separate from the counsel
employed by the Indemnitor. If the Indemnitor assumes the defense of any
Third
Party Claim, the Indemnitor will promptly supply to the Indemnitee copies
of all
correspondence and documents relating to or in connection with such Third
Party
Claim and keep the Indemnitee informed of developments relating to or in
connection with such Third Party Claim, as may be reasonably requested
by the
Indemnitee (including providing to the Indemnitee on reasonable request
updates
and summaries as to the status thereof). If the Indemnitor chooses to defend
a
Third Party Claim, all Indemnitees shall reasonably cooperate with the
Indemnitor in the defense thereof (such cooperation to be at the expense,
including reasonable legal fees and expenses, of the Indemnitor). If the
Indemnitor does not elect to assume control of the defense of any Third
Party
Claim, within the one hundred twenty (120) day period set forth above,
or if
such good faith and diligent defense is not being or ceases to be conducted
by
the Indemnitor, the Indemnitee shall have the right, at the expense of
the
Indemnitor, after three (3) Business Days notice to the Indemnitor of its
intent
to do so, to undertake the defense of the Third Party Claim for the account
of
the Indemnitor (with counsel selected by the Indemnitee), and to compromise
or
settle such Third Party Claim, exercising reasonable business
judgment.
15.2.3 Settlements.
The
Indemnitee may agree to any settlement, compromise, or discharge of such
Third
Party Claim that the Indemnitor may recommend that by its terms obligates
the
Indemnitor to pay the full amount of Losses (whether through settlement
or
otherwise) in connection with such Third Party Claim and unconditionally
and
irrevocably releases the Indemnitee completely from all liability in connection
with such Third Party Claim; provided, however, that, without the Indemnitee’s
prior written consent, the Indemnitor shall not consent to any settlement,
compromise, or discharge (including the consent to entry of any judgment),
and
the Indemnitee may refuse in good faith to agree to any such settlement,
compromise, or discharge, that provides for injunctive or other nonmonetary
relief affecting the Indemnitee. The Indemnitee shall not (unless required
by
Law) admit any liability with respect to, or settle, compromise, or discharge,
such Third Party Claim without the Indemnitor’s prior written consent (which
consent shall not be unreasonably withheld,
conditioned, or delayed).
15.3 Insurance.
Each
Party agrees to obtain and maintain commercial general liability insurance
and/or self-insurance, including prior to the date a Licensed Product is
first
administered in humans, commercial general liability insurance and/or
self-insurance for Clinical Trials and products liability, with reputable
and
financially secure insurance carriers, in such amounts and subject to such
deductibles as are
reasonable and customary in the pharmaceutical industry for companies of
comparable size and activities. Each Party shall maintain such insurance
for so
long as Licensed Products in the Territory continue to be developed,
manufactured, or commercialized and thereafter for so long as is necessary
to
cover any and all Third Party Claims required to be indemnified by such
Party
which Third Party Claims may arise from the development, manufacture, and/or
commercialization of a Licensed Product in the Territory. Upon reasonable
request by a Party, the other Party shall produce evidence that such insurance
policies are valid, kept up to date, and in full force and effect. The
insurance
obligations set forth in this Section 15.3 may be satisfied by commercially
reasonable self-insurance or a commercially reasonable combination of insurance
and self-insurance.
ARTICLE
16
TERM
This
Agreement shall become effective on the Effective Date, and unless terminated
earlier in accordance with the provisions of Article 17 shall expire
as
follows as to each Licensed Product in each country in the Territory, on
a
country-by-country basis, upon the latest of: (a) the 10th
anniversary of the date of the First Commercial Sale of the Licensed Product;
(b) the date on which the sale of such Licensed Product ceases to be covered
by
a Valid Claim in such country, or (c) in consideration of the performance
by
Chrysalis of development services without charge, the date a generic form
of the
product is introduced in such country (the “Term”).
ARTICLE
17
TERMINATION
17.1 Termination
for Material Breach.
17.1.1 Right
to Terminate Agreement.
If a
Party (the “Breaching
Party”)
commits a material breach of this Agreement and fails to cure such breach
within
the applicable Cure Period (as provided in 17.1.3
below),
the other Party (the “Non-Breaching
Party”)
may, by
written notice of termination within thirty (30) days after the expiration
of
the applicable Cure Period, elect to terminate the Agreement. Without limiting
the generality of the foregoing, and notwithstanding the Cure Period set
forth
in Section 17.1.3, the practice by Discovery of the Chrysalis Technology
outside
the scope of the licenses and sublicenses granted herein, which practice
does
not cease within thirty (30) days after the receipt of written notice of
such
breach from Chrysalis, shall constitute a material breach.
17.1.2 Right
to Terminate Supported Product Development Projects.
If a
Party (the “Breaching
Party”)
commits a material breach of its obligations in connection with a Supported
Product Development Project and fails to cure such breach within the applicable
Cure Period (as provided in 17.1.3
below),
the other Party (the “Non-Breaching
Party”)
may, by
written notice of termination within thirty (30) days after the expiration
of
the applicable Cure Period elect to terminate such Supported Product Development
Project and/or any other Supported Product Development Project that has
been
affected by such material breach. In the event that Discovery terminates
any
Supported Product Development Project pursuant to this Section 17.1.2 due
to a
material breach by Chrysalis, [***].
If such
material breach by Chrysalis also constitutes a material breach of the
Agreement, Discovery may, at its option, terminate this Agreement pursuant
to
Section 17.1.1. In the event that Chrysalis terminates any Supported Product
Development Project pursuant to this Section 17.1.2 due to a material breach
by
Discovery, [***].
If such
material breach by Discovery also constitutes a material breach of the
Agreement, Chrysalis may, at its option, terminate this Agreement pursuant
to
Section 17.1.1.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
17.1.3 Applicable
Cure Periods.
Upon
receipt of written notice of a material breach pursuant to Section 17.1.1
or
17.1.2, and except as otherwise provided for in Section 17.1.1,
the
allegedly Breaching Party shall have sixty (60) days to cure such material
breach (the “Cure
Period”),
provided, however, that in
the
case of any material breach that cannot be reasonably cured within the
sixty
(60) day cure period, should the Breaching Party deliver to the Non-Breaching
Party a plan for curing such material
breach
which is reasonably sufficient to effect a cure and uses commercially reasonable
efforts to pursue such plan and effect a cure, the Cure Period shall be
extended
for an additional sixty (60) days.
17.2 Termination
Due to Certain Events.
Without
prejudice to any other remedies available to it at Law or in equity, either
Party may, subject to the provisions set forth herein, terminate this Agreement
immediately upon written notice to the other Party if, at any time, the
other
Party shall (i) file in any court pursuant to any statute a petition for
bankruptcy or insolvency, or for reorganization in bankruptcy, or for an
arrangement or for the appointment of a receiver, trustee or administrator
of
such Party or of its assets, (ii) be served with an involuntary petition
against
it, filed in any insolvency proceeding, and such petition shall not be
dismissed
within sixty (60) days after the filing thereof, (iii) propose or be a
party to
any dissolution, (iv) make an assignment for the benefit of its creditors;
or
(v) ceases to do business in the ordinary course.
17.3 Effects
of Termination Generally
17.3.1 Accrued
Obligations; Survival. Upon
expiration or termination of this Agreement, all of the Parties’ rights and
obligations under this Agreement including the exclusive license in Section
3.1
obligations of exclusivity set forth in Section 3.5 shall terminate immediately
except: (a) any rights that shall have accrued to the benefit of any Party
prior
to such termination or expiration, including the right of Chrysalis to
receive
royalties as provided in Article 8; and (b) any rights and obligations
of the
Parties which are expressly indicated to survive termination or expiration
of
this Agreement. All of the Parties’ rights and obligations under, and the
provisions contained in [***]
shall
survive termination or expiration of this Agreement. [***]
17.3.2 Outstanding
Payments.
All
payments of amounts owing to either Party under this Agreement as of its
expiration or termination shall be due and payable within the later of
(i) to
the extent such amounts can be calculated and a fixed sum determined at
the time
of expiration or termination of this Agreement, sixty (60) days after the
date
of such expiration or termination, and (ii) ten (10) days after the date
in
which such amounts can be calculated and a fixed sum determined.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
ARTICLE
18
TECHNOLOGY
TRANSFER
18.1 Technology
Transfer.
Commencing [***]
after
the Effective Date, Chrysalis shall provide Discovery with a technology
transfer
reasonable in scope to enable the practice of the Chrysalis Technology
for
purposes of exercising the license rights granted hereunder. Upon expiration
or
termination of any Supported Product Development Project other than termination
by Chrysalis pursuant to Section 17.1 or 17.2, Chrysalis shall provide
Discovery
with an incremental technology transfer with respect to such Supported
Product
Development Project reasonable to enable the practice of the Chrysalis
Technology utilized in connection with such Supported Product Development
Project, to the extent such technology transfer has not previously
occurred.
18.2 Transfer
of Regulatory Files, Data and Filings.
In
connection with the technology transfer contemplated pursuant to Section
18.1,
Chrysalis shall provide
to
Discovery or its designee, a copy of all governmental or regulatory
correspondence, conversation logs, filings, and approvals relating to the
development, manufacture or commercialization of the Licensed Product (including
study protocols, study results, analytical methodologies, validation
documentation, and regulatory documentation) that are reasonably necessary
for
the continued development and sale of the Licensed Product. Chrysalis shall
also
provide to Discovery copies of and permit Discovery to reference in connection
with any Licensed Products all reasonably necessary Regulatory Data relating
to
Licensed Product to continue the development, marketing and sale of the
Licensed
Product. From and after such time, all such Regulatory Data and information
provided to Discovery shall remain Confidential Information of Chrysalis,
provided, however, that Discovery may use all such Regulatory Data and
information solely for the purposes of continuing to pursue the development
and
commercialization of Licensed Products. Chrysalis shall execute all documents
and take all such further actions as may be reasonably requested by Discovery
and required in order to give
effect
to the foregoing.
ARTICLE
19
STANDSTILL
AGREEMENT
19.1 General
Standstill.
Except
as set forth in this Section 19.1, Chrysalis hereby agrees that, without
the
written consent of Discovery, during the Term and for a [***]
period
beginning on the date of termination of this Agreement for any reason,
neither
Chrysalis nor any of its Affiliates will (nor assist or encourage others
to),
directly or indirectly, without the written consent of Discovery: (i) acquire,
or agree to acquire, directly or indirectly, alone or in concert with others,
by
purchase, gift, or otherwise, any direct or indirect beneficial ownership
(within the meaning of Rule 13d-3 under the Securities Exchange Act of
1934, as
amended (the “Exchange
Act”),
or
interest in any securities or direct or indirect rights, warrants, or options
to
acquire, or securities convertible into or exchangeable for, any securities
of
Discovery; (ii) directly or indirectly effect or seek, initiate, offer,
or
propose or participate in any (A) tender or exchange offer, merger,
consolidation, or other business combination involving Discovery, or (B)
any
recapitalization, restructuring, liquidation, dissolution, sale of all
or
substantially all the assets,
or other extraordinary transaction with respect to Discovery; (iii) make,
or in
any way participate in, directly or indirectly, alone or in concert with
others,
any “solicitation” of “proxies” to vote (as such terms are used in the proxy
rules of the SEC promulgated pursuant to Section 14 of the Exchange Act);
(iv)
form or become a member of a “group” (as defined under the Exchange Act) with
respect to any voting securities of Discovery (including by depositing
any
securities of Discovery in a voting trust or by subjecting any securities
of
Discovery to any other arrangement or agreement with respect to the voting
of
such securities); or (v) enter into any agreements, discussions, or arrangements
with any Third Party with respect to any of the foregoing.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
19.2 Certain
Exceptions.
Nothing
in this Article 19 shall prohibit Chrysalis’ or its Affiliates’ employees from
purchasing securities of Discovery pursuant to (i) a pension plan established
for the benefit of Chrysalis’ or its Affiliates’ employees, (ii) any employee
benefit plan of Chrysalis or its Affiliates, (iii) any stock portfolios
not
controlled by Chrysalis or any of its Affiliates that invest in Discovery
among
other companies, or (iv) de
minimis
passive
investments not to exceed five percent (5%) of Discovery’s outstanding voting
securities.
19.3 Exception
for an Acquisition Transaction.
This
Article 19 shall terminate (subject to revival as provided below) and Chrysalis
and its Affiliates shall have the right to acquire any securities of Discovery
without regard to the limitations set forth in this Article 19 in the event
that
Discovery publicly announces a transaction, an intention or desire to effect
any
transaction, or the receipt of any offer, which would result in (a) the
sale of
all or substantially all of the assets of Discovery within the meaning
of
Section 271 of the Delaware General Corporation Law, or (b) Discovery common
shareholders immediately prior to such transaction owning less than fifty
percent (50%) of the outstanding common stock of the acquiring entity or,
in the
case of a merger transaction, the surviving corporation (an “Acquisition
Transaction”).
If
the proposed Acquisition
Transaction has
not
been consummated within six (6) months following Discovery’s public announcement
in respect thereof, the provisions of this Article 19 shall be revived
and have
full force and effect until such time as Discovery makes a subsequent public
announcement regarding an Acquisition Transaction, at which time the provisions
of this Article 19 shall once again apply.
19.4 Other
Agreements.
Notwithstanding anything in this Agreement to the contrary, Discovery agrees
that if, subsequent to the date hereof and prior to the end of the [***] period
following
the Term, any other party which becomes a licensee of Discovery patents
or other
technology does not agree to the terms contained in this Article 19, or
agrees
to terms that are materially less restrictive to such other party than
those
contained in this Article 19, then Discovery will so notify Chrysalis,
and will
as appropriate describe in such notice any such less restrictive terms
and, if
Chrysalis elects, the provisions of this Article 19 will be deemed to have
been
modified to delete the provisions of this Article 19 or to provide Chrysalis
with the benefit of such materially less restrictive terms, as
appropriate.
Information
marked by [***] has been omitted pursuant to a request for confidential
treatment. The omitted portion has been separately filed with the Securities
and
Exchange Commission.
ARTICLE
20
DISPUTE
RESOLUTION
20.1 Dispute
Resolution.
Except
as expressly otherwise provided in this Agreement, any material dispute,
difference, claim, action, demand, request, investigation, controversy,
threat
or other question arising out of or relating to the interpretation of any
provisions of this Agreement or the failure of any Party to perform or
comply
with any obligations or conditions applicable to such Party pursuant to
this
Agreement unresolved by the Steering Committee (a “Dispute”) shall be settled in
accordance with the provisions of this Article 20; provided, however, that
after
the expiration or termination of this Agreement, such Disputes shall be
referred
directly to the senior executives of the Parties as provided for in Section
20.2. If a Party intends to initiate executive negotiation, mediation or
arbitration (as set forth below) to resolve a Dispute, such Party shall
provide
written notice to the other Party informing such other Party of such intention
and the issues to be resolved.
20.2 Escalation
and Executive Negotiation.
Any
dispute or disagreement between the representative of Discovery and Chrysalis
on
the Project Team as to matters within such Project Team’s jurisdiction shall, at
the election of either Party, be addressed, first, with the Alliance Managers,
and if the dispute is not resolved within ten (10) Business Days after
such
referral to the Alliance Managers, then it shall, at the election of either
Party, be submitted to the Steering Committee for resolution, provided
however
that after the expiration or termination of this Agreement, such disputes
shall
be referred directly to the senior executives of the Parties as provided
for in
this Section 20.2. The Steering Committee shall attempt in good faith to
resolve
any issues presented to it.
If
the
Steering Committee, after acting in good faith and in a diligent manner,
is
unable to resolve any Dispute submitted to it within a reasonable period
of time
and in any event within thirty (30) days of such submission, such matter
shall,
at the election of either Party, be
referred
for good faith negotiation to a senior executive of each Party.
20.3 Mediation.
If the
senior executives referenced in Section 20.2 are unable to resolve
any such
Dispute within ten (10) Business Days, either Party may, upon written notice
to
the other Party, refer such Dispute to mediation. Upon such written notice,
the
Parties shall mutually agree on a mediator to assist in the negotiations.
If the
Parties fail to mutually agree on a mediator within one week of the written
notice, a mediator shall be appointed by the AAA. The Party responsible
for
referring the Dispute to mediation shall bear the costs of such mediation.
Any
settlement reached by mediation shall be resolved in writing, signed by
the
Parties, and shall be binding on them.
20.4 Arbitration.
20.4.1 Referral
to Arbitration.
In the
event that a Dispute is not resolved during mediation within thirty (30)
days of
the selection of a mediator, either Party may refer such Dispute to final
and
binding arbitration by sending written notice of such election to the other
Party clearly marked “Arbitration Demand,” whereupon such Dispute shall be
arbitrated in accordance with this Section 20.4.
20.4.2 Rules
and Procedures.
Except
as expressly otherwise provided in this Agreement, any Dispute shall be
finally
settled by arbitration under the then-current expedited procedures applicable
to
the then-current Commercial Arbitration Rules of the AAA in accordance
with the
terms set forth in this Section
20.4.
The arbitration of any Dispute shall be kept confidential and shall be
filed
with the office of the AAA located in Washington, D.C. or such other AAA
office
as the Parties may agree. Such arbitration shall be conducted by three
arbitrators, one appointed by each of Chrysalis and Discovery and the third
selected by the first two appointed arbitrators. Each arbitrator shall
be a
person with relevant experience in the pharmaceutical industry. Chrysalis
and
Discovery must make their respective arbitrator appointments within ten
(10)
Business Days of notice being given to a Party by the other Party of its
intention to resolve such Dispute through arbitration. Such appointed
arbitrators shall select the third arbitrator within ten (10) Business
Days of
the last to occur of their respective appointments. Chrysalis and Discovery
shall instruct such arbitrators to render a determination of any such Dispute
within sixty (60) days after the appointment of the third arbitrator. All
Disputes shall be resolved by submission of documents unless the arbitration
panel determines that an oral hearing is necessary.
20.4.3 Awards.
The
decision of the arbitrators with respect to any Dispute shall be in writing
and
state the findings, facts and conclusions of law upon which the decision
is
based. Any such decision and award rendered by the arbitrators shall be
final
and binding upon the Parties. Judgment upon any award rendered may be entered
in
any court having jurisdiction, or application may be made to such court
for a
judicial acceptance of the award and an order of enforcement, as the case
may
be. Each Party submits itself to the jurisdiction of any such court for
the
entry and enforcement to judgment with respect to the decision of the
arbitrators hereunder. The arbitrators shall have the power to grant all
legal
and equitable remedies except specific performance and award compensatory
damages provided by applicable law, but shall not have the power or authority
to
award punitive damages. No Party shall seek punitive damages or specific
performance in relation to any matter under, arising out of, or in connection
with or relating to this Agreement in any other forum, provided however,
that
the foregoing does not preclude suits or limit damages associated with
infringement.
20.4.4 Costs.
Each
Party shall pay its own expenses of arbitration, and the expenses of the
arbitrators shall be equally shared between Chrysalis and Discovery unless
the
arbitrators assess as part of their award all or any part of the arbitration
expenses of a Party or Parties (including reasonable attorneys’ fees) against
the other Party or Parties, as the case may be.
20.4.5 No
Other Forum.
Except
as provided in Section 20.5, the provisions of this Section 20.4 shall
be a
complete defense to any suit, action or proceeding instituted in any federal,
state or local court or before any administrative tribunal with respect
to any
Dispute arising under this Agreement. Any Party commencing a lawsuit in
violation of this Section 20.4 shall pay the costs of the other Party,
including, without limitation, reasonable attorney’s fees and defense
costs.
20.5 Right
to Injunctive and Other Relief.
Nothing
in this Agreement, shall prohibit
either Party from seeking injunctive relief from a court of competent
jurisdiction in the event of a breach or prospective breach of this Agreement
by
the other Party which would cause irreparable harm to the first Party.
Nothing
in this Agreement shall prevent a Party from seeking any remedies available
at
law or in equity in any court of competent jurisdiction in the event of
the
practice of such Party’s Intellectual Property outside the scope of the rights
granted herein.
ARTICLE
21
MISCELLANEOUS
21.1 Choice
of Law.
This
Agreement shall be governed by and interpreted under, and any action or
proceeding shall apply, the Laws of the State of New York excluding (i)
its
conflicts of Laws principles, other than Section 5-1401 of the New York
General
Obligations Law (ii), the United Nations Conventions on Contracts for the
International Sale of Goods and (iii) the 1974 Convention on the Limitation
Period in the International Sale of Goods and any Protocols thereto, done
at
Vienna, April 11, 1980.
21.2 Severability.
If,
under Law, any provision of this Agreement is invalid or unenforceable,
or
otherwise directly or indirectly affects the validity of any other material
provision(s) of this Agreement, this Agreement shall endure except for
such
provision. The Parties shall consult one another and use their best efforts
to
agree upon a valid and enforceable provision that is a reasonable substitute
for
such invalid or unenforceable provision in view of the intent of this
Agreement.
21.3 Relationship
of the Parties.
Each
Party shall bear its own fees, expenses, and disbursements, including the
fees
and expenses of their respective counsel, accountants, bankers, and other
experts, in connection with the subject matter of this Agreement and costs
incurred in the performance of its obligations hereunder without charge
or
expense to the other except as expressly provided in this Agreement. Neither
Party shall have any responsibility for the hiring, termination or compensation
of the other Party’s employees or for any employee benefits of such employee. No
employee or representative of a Party shall have any authority to bind
or
obligate the other Party to this Agreement for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability on
the
other Party without said Party’s approval. For all purposes, and notwithstanding
any other provision of this Agreement to the contrary, the Parties’ legal
relationship under this Agreement shall be that of independent contractors.
This
Agreement is not a partnership agreement and nothing in this Agreement
shall be
construed to establish a partnership, joint venture, agency, or
employer-employee relationship between the Parties.
21.4 Parties
in Interest.
This
Agreement shall be binding upon and inure to the benefit of and be enforceable
by the respective legal representatives, successors, and permitted assigns
of
the Parties hereto. Nothing in this Agreement, express or implied, is intended
to confer on any Person
other than the Parties hereto, or their respective successors and assigns,
any
rights, remedies, obligations, or liabilities under or by reason of this
Agreement.
21.5 Enforcement
of Certain Agreements.
Each
Party shall use commercially reasonable efforts at its expense to enforce
the
provisions of any confidentiality agreements and agreements with respect
to
noncompetition existing as of the Effective Date with any of its present
or
former employees, agents, consultants or independent contractors of Discovery
that relate to any Licensed Product; provided, however, that the obligation
with
respect to any agreement related to this Section 21.5 shall terminate as
of the
date on which such agreement and the obligations regarding noncompetition
have
terminated or expired in accordance with its terms.
21.6 Use
of
Affiliates, Subcontractors, Sublicensees and Distributors.
Each
Party shall have the right to use Affiliates, subcontractors, sublicensees
and
distributors in exercising its rights and carrying out its obligations
under
this Agreement, provided, however, that (i) such entities agree in writing
to be
bound by the provisions of Article 11, (ii) the use of such entities does
not in
any way materially diminish the other Party’s rights or otherwise modify the
other Party’s rights or obligations hereunder without such other Party’s prior
written consent, (iii) Discovery may not delegate, sublicense, assign,
or
otherwise transfer any of its rights or obligations hereunder to any entity
(including any Affiliate) that competes with any tobacco product of Chrysalis
or
its Affiliates or a company engaged in the development or sale of Aerosol
Technologies without Chrysalis’ prior written consent, (iv) Chrysalis may not
delegate, assign or otherwise transfer any of its rights or obligations
hereunder to a company engaged in pulmonary critical care medicine, without
Discovery’s prior written consent and (v) except with respect to rights,
benefits and obligations assigned as permitted pursuant to Section 21.7,
each
Party shall be liable for any actions or omissions of its Affiliates,
subcontractors, sublicensees and distributors in connection with this Agreement
and the Intellectual Property and Confidential Information of the other
Party to
the same extent as if such actions or omissions were conducted by the Party
itself.
21.7 Assignment.
Chrysalis
may assign or otherwise transfer this Agreement or any or all right, benefit
or
obligation hereunder (whether by operation of Law or otherwise) to any
Affiliate
of Chrysalis without the prior written consent of Discovery subject only
to the
limitations set forth in Section 21.6 (iv) above. Discovery may assign
or
otherwise transfer this Agreement or any or all right, benefit or obligation
hereunder (whether by operation of Law or otherwise) to any Affiliate of
Discovery without the prior written consent of Chrysalis, subject only
to the
limitations set forth in Section 21.6 (iii) above, provided, however,
notwithstanding such an assignment, Discovery shall remain responsible
for the
performance of the indemnification obligations set forth herein. No Party
may
assign or otherwise transfer this Agreement or any or all right, benefit
or
obligation hereunder (whether by operation of Law or otherwise) to any
other
Person other than an Affiliate without the prior written consent of the
other
Party, which consent shall not be unreasonably withheld, conditioned, or
delayed; except that, subject to the limitations set forth in Section 21.6
(iii)
and (iv) above, either Party may assign or otherwise transfer any or all
of its
rights and interests hereunder in connection with the sale of all or
substantially all of its assets or business to which this Agreement relates,
whether by way of merger, sale of stock, sale of assets or other similar
transaction, provided that the assignee or transferee expressly agrees
to assume
all of the obligations hereunder.
21.8 Further
Assurances and Actions.
From
time to time after the Effective Date, Discovery and Chrysalis shall execute,
acknowledge and deliver to each other any further documents, assurances,
and
other matters, and will take any other action consistent with the terms
and
conditions of this Agreement, that may reasonably be requested by a Party
and
necessary or desirable to carry out the purpose and intent of this Agreement.
Chrysalis and Discovery shall cooperate and use all reasonable efforts
to make
all other registrations, filings, and applications, to give all notices,
and to
obtain as soon as practicable all governmental or other consents, transfers,
approvals, orders, qualifications, authorizations, permits, and waivers,
if any,
and to do all other things necessary or desirable for the consummation
of this
Agreement.
21.9 Waiver.
Any
term or condition of this Agreement may be waived at any time by the Party
that
is entitled to the benefit thereof, but no such waiver shall be effective
unless
set forth in a written instrument duly executed by or on behalf of the
Party
waiving such term or condition. No waiver by any Party of any term or condition
of this Agreement, in any one or more instances, shall be deemed to be
or
construed as a waiver of the same or any other term or condition of this
Agreement on any future occasion. Except as expressly set forth in this
Agreement, all rights and remedies available to a Party, whether under
this
Agreement or afforded by Law or otherwise, will be cumulative and not in
the
alternative to any other rights or remedies that may be available to such
Party.
21.10 Section
365(n) of the Bankruptcy Code.
All
rights and licenses granted under or pursuant to any section of this Agreement
are, and shall otherwise be deemed to be, for purposes of Section 365(n)
of the
Bankruptcy Reform Act of 1978, 11 U.S.C. §§ 101 et
seq.,
as
amended (the “Bankruptcy
Code”),
licenses of rights to “intellectual property” as defined under
Section 101(35A) of the Bankruptcy Code. The Parties shall retain
and may
fully exercise all of their respective rights and elections under Section
365(n)
of the Bankruptcy Code.
21.11 Notices.
All
notices that are required or permitted hereunder shall be in writing and
shall
be sufficient if personally delivered or sent by mail or Federal Express
or
other delivery service. Any notices shall be deemed given upon the earlier
of
the date when received at, or the third day after the date when sent by
registered or certified mail or the day after the date when sent by Federal
Express to, the address set forth below, unless such address is changed
by
notice to the other Parties hereto:
If
to
Chrysalis:
Chrysalis
Technologies
615
Maury
Street
Richmond,
VA 23224
Attention:
Timothy Beane
If
to
Discovery:
Discovery
Laboratories, Inc.
2600
Kelly Road, Suite 100
Warrington,
PA 18976
Attention
: David L. Lopez, Esq., CPA
with
a
copy to:
Dickstein
Shapiro Morin & Oshinsky, LLP
1177
Avenue of the Americas, 47th
Fl
New
York,
NY 10036
Attention:
Ira L. Kotel, Esq.
21.12 Construction.
Unless
the context of this Agreement clearly requires otherwise, (i) references
to any
gender include all genders, (ii) “or” has the inclusive meaning frequently
identified with the phrase “and/or,” (iii) “including” has the inclusive meaning
frequently identified with the phrase “including but not limited to” or
“including without limitation”, and (iv) references to “hereunder” or “herein”
relate to this Agreement and (v) all terms defined in the singular shall
have
the same meaning in the plural and visa versa. The section and other headings
contained in this Agreement are for reference purposes only and shall not
control or affect the construction of this Agreement or the interpretation
thereof in any respect. Section, subsection, Schedule and Exhibit references
are
to this Agreement unless otherwise specified. Each accounting term used
herein
that is not specifically defined herein shall have the meaning given to
it under
GAAP.
21.13 Registration
and Filing of this Agreement.
To the
extent, if any, that either Party concludes in good faith that it or the
other
Party is required to file or register this Agreement or a notification
thereof
with any Regulatory Authority, including the SEC or the U.S. Federal Trade
Commission, in accordance with Law, such Party shall inform the other Party
thereof. Should both Parties jointly agree that either of them is required
to
submit or obtain any such filing, registration or notification, they shall
cooperate, each at its own expense, in such filing, registration or notification
and shall execute all documents reasonably required in connection therewith.
In
such filing, registration or notification, the Parties shall request
confidential treatment of sensitive provisions of this Agreement, to the
extent
permitted by Law. The Parties shall promptly inform each other as to the
activities or inquiries of any such Regulatory Authority relating to this
Agreement, and shall reasonably cooperate to respond to any request for
further
information therefrom on a timely basis.
21.14 Force
Majeure.
No
Party shall be held liable or responsible to the other Party nor be deemed
to be
in default under, or in breach of any provision of, this Agreement for
failure
or delay in fulfilling or performing any obligation of this Agreement when
such
failure or delay is due to Force Majeure, and without the fault or negligence
of
the Party so failing or delaying. For purposes of this Agreement, Force
Majeure
is defined as causes beyond the control of the Party, including, without
limitation, acts of God; acts, regulations, or laws of any government;
war;
civil commotion; destruction of production facilities or materials by fire,
flood, earthquake, explosion or storm; labor disturbances; epidemic; and
failure
of public utilities or common carriers. In such event Discovery or Chrysalis,
as
the case may be, shall immediately notify the other Party of such inability
and
of the period for which such inability is expected to continue. The Party
giving
such notice shall thereupon be excused from such of its obligations under
this
Agreement as it is thereby disabled from performing for so long as it is
so
disabled and the thirty (30) days thereafter. To the extent possible, each
Party
shall use reasonable efforts to minimize the duration of any Force
Majeure.
21.15 Entire
Agreement.
This
Agreement constitutes the entire agreement between the Parties with respect
to
the subject matter and supersedes all previous agreements and understandings
between the Parties, whether written or oral. This Agreement may be altered,
amended or changed only by a writing making specific reference to this
Agreement
and signed by duly authorized representatives of Discovery and
Chrysalis.
21.16 Third
Party Beneficiaries.
Except
for any Third Party Indemnities under Article 15, none of the provisions
of this
Agreement shall be for the benefit of or enforceable by any Third Party,
including any creditor of either Party hereto, and no such Third Party
(except
for such Indemnitees, as such) shall obtain any right under any provision
of
this Agreement or shall by reasons of any such provision make any claim
in
respect of any debt, liability or obligation (or otherwise) against either
Party
hereto.
21.17 Execution
in Counterparts; Facsimile Signatures.
This
Agreement may be executed in counterparts, each of which counterparts,
when so
executed and delivered, shall be deemed to be an original, and both of
which
counterparts, taken together, shall constitute one and the same instrument
even
if both Parties have not executed the same counterpart. Signatures provided
by
facsimile transmission shall be deemed to be original signatures.
[Signature
Page Follows]
IN
WITNESS WHEREOF, this Agreement has been executed by the Parties hereto
as of
the day and year first written above.
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PHILIP
MORRIS USA INC.,
d/b/a
CHRYSALIS TECHNOLOGIES
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By: |
/s/ John
R. Nelson |
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Name: John
R. Nelson
Title: President,
Operations and Technology
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DISCOVERY
LABORATORIES, INC. |
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By: |
/s/ Robert
J. Capetola |
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Name: Robert
J. Capetola, Ph.D.
Title:
President
and Chief Executive Officer
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